cvc chronicle fall 2013
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CANADIAN
VIGOUR CENTRE
Inside this
issue:
CVC is proud
to be a
University of Alberta
Centre
Bridging hearts
and minds to enhance
cardiovascular care
www.vigour.ualberta.ca
Letter -
PW Armstrong
1
Trial Updates 2-5
Monitoring
6
CVC
News 6
CVC
Publications 7-8
Recently I have been engaged with my colleagues at the Canadian VIGOUR Centre in creating our annual report
for 2012, which celebrates CVC’s 15th year as an ARO (academic research organization), and a significant wealth
of trial experience, along with peer reviewed publications and ample mentoring opportunities for our next
generation of health researchers. The exercise of generating an annual report gives me pause to reflect on our
collective contributions to date, but also to examine and articulate our future direction(s) as it relates to our
overall role in the cardiovascular research arena in Canada and our raison d’être. As part of our annual faculty
Advance (I avoid Retreats), we illustrated our organizational purpose and future direction into what we term the
CVC Compass, as borrowed from the Harvard Business Review’s assessment of the Four Seasons Hotel
approach. This compass is now displayed on the back cover of this edition of the Chronicle, in our latest annual
report, as well as our web site (http://www.vigour.ualberta.ca/About.aspx). This exercise of “calibrating our
compass”, that is, setting our objectives and strategic priorities, has helped us in reflecting on who we are and
where we are headed. I also believe it will be useful to new staff and our community of investigators and many
colleagues worldwide.
Although the term ARO is in common use, its meaning is less clear: ironically this is especially true for many of
our colleagues within the university and health care environment. Four years ago I attempted a definition which
still resonates and is referred to in our annual report. I include it here to remove unnecessary ambiguity:
“An ARO in my view possesses scholarly values of inquiry and truth, shares knowledge in an ethical framework, is dedicated
to enhancing public health, and values discovery, novel approaches and methodologies over profit. It strives to achieve the
operational efficiency of a CRO (contract research organization) and is directly linked to patient care and the bedside. It is
almost always embedded in a university, functions on a not-for-profit basis, is committed to the education of the next
generation of professionals and fulfills its contract with society by emphasizing the public good.”
In these challenging times for clinical research, collaborators are key to a preferred future. Our faculty has been
significantly strengthened by the addition of Shaun Goodman from the University of Toronto who is also an
Adjunct Professor of Medicine at the University of Alberta. Shaun is now playing a leadership role in two of our
major CVC trials described elsewhere in the Chronicle and is actively engaged in our overall activities. This
development signals a new east-west Canadian axis in clinical research. A key responsibility Shaun holds, as the
Heart & Stroke Foundation Polo Chair, is to assist in mentoring young clinical investigators, a commitment we
enthusiastically share. We continue and have recently enriched our long standing collaboration with the Duke
Clinical Research Institute, now led by Eric Peterson. This north-south axis is key to the future of our
collaborative North American research endeavors as an ARO and fundamental to where our compass points.
As this edition of the Chronicle takes flight, our attention turns to the Canadian Cardiovascular Society meeting
in Montreal October 17-20th where our PROACT work will unfold and the American Heart Association meeting
in November where new insights from STREAM into aborted MI, the approach to rescue coronary intervention
and the much anticipated one year follow up, will be presented.
We invite our many friends and co-investigators to join us during the 19th annual Beyond 2000 symposium to be
held Thursday morning October 17, 2013 and look forward to seeing them participate in what promises to be a
terrific program as noted in this edition of the Chronicle. For more information on the Beyond 2000 symposium,
please go to the website www.beyond2000.org.
With kind regards,
Paul W. Armstrong, MD
Fall 2013 Volume 17, No. 2
The Canadian
Cardiac Chronicle Letter from Dr. Paul Armstrong:
Page 2 The Canadian Cardiac Chronicle
IMProved Reduction of
Outcomes: Vytorin Efficacy
International Trial
Sponsored by Merck & Co.
Inc., (previously Schering-
Plough Research Institute)
this trial is a multicenter,
double-blind, randomized
study to establish the
clinical benefit and safety of
Vytorin (ezetimibe/
simvastatin Tablet) vs.
simvastatin monotherapy in
high-risk patients
presenting with acute
coronary syndrome.
ClinicalTrials.gov
Identifier: NCT00202878
IMPROVE-IT
The IMPROVE-IT trial is projected to reach
the protocol-defined number of clinical
endpoints in 2014. Patient retention continues
to be paramount to ensuring we reach our
target number of endpoints. The countdown
is on as we head towards the finish line!
In preparing the database for study closure,
Memo #408 recently came out, where QC of
AEs and potential clinical endpoints is being
conducted. Your cooperation in addressing
any of these important “AEQC” data queries
within 10 days is appreciated.
Reminders:
(1) CVC no longer tracks REB submissions/
acknowledgements of external SAEs. Though
sites must submit external SAEs to their REBs,
per their REB guidelines, they no longer need
to send copies of their REB correspondence to
CVC for these external safety reports. This
documentation should be filed at your site.
(2) Should a patient permanently discontinue
study drug, please remember to make the
withdrawal call in IVRS as well.
Data Clean Up – Commendations to the
following sites that have achieved 100% clean
data as of Sep06’2013:
2052 – Vancouver General Hospital,
PI—Dr. Wong, SC - Naomi Uchida
2054 – Surrey Memorial Hospital,
PI—Dr. Cheung, SC - Tracy Cleveland
2067 – Scarborough Cardiology Research,
PI—Dr. Mukherjee, SC - Kim Brown
2071 – Yamaska (CSSSHY),
PI—Dr. Brossoit, SC - Celine Peck
2075 – Montreal General Hospital,
PI—Dr. Huynh, SC - Barbara St. Jacques
2080 – Hôpital Pierre Le Gardeur,
PI—Dr. Gosselin, SC - Margaux David
2089 – Hôpital Laval,
PI—Dr. DeLarochelliere, SC - Melanie
Roy
2090 – St. Catharines Hospital,
PI—Dr. Pallie, SC - Sheila Krekorian
2098 – Hôtel-Dieu de Lévis,
PI—Dr. Grondin, SC - Noella Bilodeau
CEC Adjudicated Events – please remember to
submit any outstanding (de-identified) source
documents to the CEC.
For further information, please contact Clinical
Trial Project Lead, Jodi Parrotta at
1-800-707-9098, ext. 3 or by email at
jodi.parrotta@ualberta.ca.
STABILITY
Thanks to all our Canadian sites who have
been working hard toward study closeout and
quickly answering any outstanding queries.
As we work to close-out the regulatory files
for the study, remember if you have not al-
ready submitted your end of study financial
disclosure forms and ethics study closeout
letters please email or fax them to us now at
780-492-0613. We will be doing one final
review/reconciliation of the files and contacting
you to collect any of the final documents that
we may be missing.
This is an exciting time for the trial as we all
anticipate the presentation of the results in the
near future.
For further information, please contact Assis-
tant Director, Clinical Trials, Tracy Temple at
1-800-707-9098 Option 5 or by email at
tracy.temple@ualberta.ca.
STabilisation of
Atherosclerotic plaque By
Initiation of darapLadIb
TherapY
Sponsored by Glaxo
SmithKline, this trial is a
randomized, placebo-
controlled, double-blind,
parallel group, multicenter,
event-driven clinical
outcomes study of
darapladib versus placebo
in subjects with chronic
coronary heart disease to
compare the incidence of
major adverse
cardiovascular events.
ClinicalTrials.gov Identifier: NCT00799903
Page 3 Volume 17, No. 2
Exenatide Study of
Cardiovascular Event
Lowering
Sponsored by Amylin
Pharmaceuticals, Inc. this
trial is a pragmatic, long
term, placebo-controlled,
double-blinded trial which
seeks to characterize the
effects of exenatide once
weekly on cardiovascular
(CV) -related outcomes in
patients with type 2
diabetes when added to
the current usual care for
glycemic control in a
standard care setting.
ClinicalTrials.gov Identifier: NCT01144338
After careful consideration of the protocol in
early 2013, it was decided that modifications to
the protocol and trial processes were neces-
sary. Input was received from many trial col-
laborators and the next phase was initiated in
July 2013. We are pleased to report that the
updated processes made a smooth transition
and as of 27 September 2013, 116 patients
have been randomized. The data from the patients enrolled in
2011/2012 will be presented at the Canadian
Cardiovascular Congress in Montreal on
It has been a busy few months for the EXSCEL
trial. Global enrollment is now over 7900 with
Canada having enrolled 293 patients. Canada
currently has 24 sites activated and we are
excited to announce that we are planning for
an upcoming expansion of 5 new Canadian
sites.
The Amendment 4 transition is now well
underway with the first wave of Canadian sites
already successfully transitioned. Our goal is to
have all sites transitioned by the end of
October; to that end we will continue to work
closely with our sites. Please remember that
prior to transitioning, all regulatory documents
must be in order and all study staff must have
received appropriate training. If you have any
questions or concerns related to the transition
process, please contact the Project Team.
Thank you for all your hard work in cleaning
up the study data prior to the data lock on
August 30th in preparation for the next DSMB
meeting in October. We were able to achieve
94% site clean data. A special thank you to
those sites achieving 100% site clean data:
Vancouver General Hospital,
PI—Dr. T. Elliott, SC - Marla Inducil
Fraser Clinical Trials,
PI—Dr. R. Kuritzky, SC - Carol Marchand
Centre de Cardiologie et de Recherche
Clinique de Laval,
PI—Dr. Y. Robitaille, SC - Christine
Masson
St. Michael’s Health Centre,
PI—Dr. L. Leiter, SC - Danielle Bedard
McMaster University,
PI—Dr. Z Punthakee, SC - Irene Stanton
EXSCEL
Institut Universitaire de Cardiologie et de
Pneumologie de Québec,
PI—Dr. F. Dube, SC - Marilène Bolduc
Clinical Trial Unit at the University of
Calgary,
PI—Dr. R. Sigal, SC - Mary Ann
Clearwaters
Congratulations to our top five recruiters as of
September 5th 2013:
Dr. Ronald Bourgeois, Moncton NB – 38
pts
Dr. Thomas Elliott, Vancouver BC – 26
pts
Dr. Richard Dumas, Laval QC – 23 pts
Dr. Vincent C. Woo, Winnipeg MB – 21
pts
Dr. Ron Sigal, Calgary AB – 20 pts
As a reminder Courtney Bryden will be
starting her maternity leave on Sept 19 and
Amanda Carapellucci has stepped in as her
replacement over the next year. Moving
forward please contact Amanda and Diane for
all trial related questions. We would like to
thank Courtney for all her hard work on
EXSCEL and wish her all the best. (See
Amanda’s bio on page 6 announcements.)
We thank you for your continued support of
the EXSCEL trial!
For further information please contact Clinical
Trial Project Lead, Amanda Carapellucci at 1-
800-707-9098 (Ext 2) or by email at
amanda.carapellucci@ualberta.ca or Diane
Camara at 1-800-725-6585 or by email at
dcamara@chrc.net.
PROACT—A local initiative Providing Rapid Out of
Hospital Acute
Cardiovascular Treatment
An Edmonton-region local
initiative sponsored by the
University Hospital
Foundation and the
Mazankowski Alberta
Heart Institute. Additional
support for point of care
meters provided by Alere
Inc.
ClinicalTrials.gov
Identifier: NCT01634425
PROACT
October 20, 2013 @ 0930 by Dr. Justin Eze-
kowitz - “Providing Rapid Out Of Hospital
Acute Cardiovascular Treatment (PROACT-3):
Insights from the Field”.
For further information please contact Paula
Priest at 1-800-707-9098 (ext 9) or email at
paula.priest@ualberta.ca.
The Canadian Cardiac Chronicle Page 4
ODYSSEY OUTCOMES
Sponsored by Sanofi-
aventis Recherche &
Développement this is a
randomized, double-blind,
placebo-controlled, parallel
-group study to evaluate
the effect of SAR236553/
REGN727 on the
occurrence of cardiovascu-
lar events in patients who
have recently experienced
an Acute Coronary
Syndrome.
ClinicalTrials.gov
Identifier: NCT01663402
The ODYSSEY Outcomes study is now well
underway around the world with over 900
patients randomized. In Canada we have
activated over 20 sites and are looking forward
to seeing screening and recruitment efforts
increase throughout the next couple months at
all sites. Congratulations to Dr. Ronald Bourgeois and
the team (Sub-Investigator, Dr. Daniel Landry;
Study Coordinators Glenda Shea-Landry,
Jennifer Lambert and Karen Boyd) at G.A.
Research Associates in Moncton, NB for
screening and randomizing the first patient in
Canada! This is a significant milestone for the
study in Canada and many thanks for all your
hard work!
We would also like to acknowledge the
following sites that we have added to the “first
patient randomized list” for the study. Keep
up the great work!
Dr. James Cha, Judy Otis and Elizabeth
Burke in Oshawa, ON
Dr. Manohara Senaratne, Robin Varughese
and Denali Perera in Edmonton, AB
Dr. Christopher Lai and Marnie Jarvis in
Thunder Bay, ON
Dr. Paul MacDonald and Joy Howard
in Sydney, NS
Dr, Jan Kornder, Dale Kastanis and Lynn
Breakwell in Surrey, BC
We will be working hard to get the remainder
of our sites activated in the next few months.
Don’t forget to get all your training complete
and regulatory in while you are waiting on
contracts and ethics!
We would like to send out the challenge
to all of our sites to put all eyes on
ODYSSEY over that next month and
let’s see how many patients we can find
in Canada!
For those sites that have now screened and/or
randomized a patient, don’t forget to complete
your CRF’s and answer any open queries. We
have had many great questions over the last
several months, especially from those of you
starting to screen and recruit patients. Keep
them coming and watch for FAQ’s in the
newsletters and updates sent out to you
throughout the trial.
We are still recruiting a few final sites for this
study so if you are interested in hearing more
about ODYSSEY Outcomes or if you are a site
and have questions regarding ODYSSEY
Outcomes please contact Robert Evans at
robert.evans@ualberta.ca or 1-800-707-9098
Option 1.
REGULATE PCI
CVC is buzzing with excitement on this long
awaited PCI trial, as we work to start up 20
centres across Canada and enroll over 13,000
patients globally in the next couple years.
Hats off to Dr. Warren Cantor and his
Study Coordinator Kim Robbins with the
York PCI Group in Newmarket, ON for
a record start up. They are not only the
first site activated in Canada but one of the
first 4 sites activated for the trial. Only a cou-
ple days after receiving study drug we are
pleased to share that they have already recruit-
ed 5 patients. Thanks to them and their team
at York PCI for all their hard work to make
this happen.
We have had a tremendous response from our
Canadian sites on this study and are now ac-
tively working through start-up with the plan
to have many of our Canadian sites activated
over the next couple months. If you are one of
our participating sites, we will be working with
you to ensure all ethics submissions are in by
mid-Oct. Please email your regulatory docu-
ments for review as they become completed.
We look forward to seeing some of our inves-
tigators and study coordinators next month in
Chicago for our first investigator meeting.
For further information, or if you are interest-
ed in participating, please contact Clinical Trial
Project Lead, Jodi Parrotta at 1-800-707-9098,
ext. 3 or by email at jodi.parrotta@ualberta.ca.
Sponsored by Regado
Biosciences Inc. this is a
randomized, open-label,
multi-center, active-
controlled, parallel group
study to determine the
efficacy and safety of the
REG1 Anticoagulation
System Compared to
Bivalirudin in Patients
Undergoing Percutaneous
Coronary Intervention
Clinical trials.gov
Identifier: NCT01848106
Page 5 Volume 17, No. 2
TECOS
With the expected study end date on target
for the latter part of 2014, the pressure is on
to maintain or improve our patient retention
numbers and to clean up data!
Our Canadian TECOS sites have done an
excellent job of retaining patients in the study
and keeping our withdrawn consent or lost to
follow-up numbers low. We do, however,
need to be vigilant about the number of
patients permanently discontinuing study drug.
It is essential that Principal Investigators are
involved in any decision to discontinue study
drug and that these decisions are well-
documented at the site. You have put such
tremendous effort into the TECOS study over
the last several years we want to ensure that
the end result is meaningful!
The Inform data complete and clean rates in
Canada continue to be impressive at 98% to
99%. One of the main data priorities now as
we near the finish line is to ensure that data is
being entered in a timely manner after visits so
that the Project Team can keep a close eye on
patients that may be at risk for becoming lost
to follow-up. The other priority is to ensure
that CEC queries are being taken care of
quickly and thoroughly. TECOS is a
cardiovascular outcomes driven trial and will
continue until the required CV events have
been accrued . The Clinical Events Committee
must receive all of the appropriate information
– all required source documents provided and
requests for additional data needed, before
adjudication can be completed. We can’t do
this without your help!
Congratulations to the following sites that
have 100% clean data!
Dr. Sigalas & Darlene Hutton – Rouge
Valley Metabolic Research Associates,
Scarborough, ON
Dr. Yale & Mylene Roy – Royal Victoria
Hospital, Montreal, QC
Dr. Saunders & Lori Richert – Rivergrove
Medical Clinic, Winnipeg, MB
A TECOS rejuvenation meeting is in the
planning stages and will likely occur this
November. Please keep an eye out for further
communications coming via email in the near
future.
For further information, please contact Clinical
Trial Project Lead, Lyndsey Garritty at
1-800-707-9098, ext 4 or via email at
lyndsey.garritty@ualberta.ca.
Sponsored by Merck & Co.
Inc., TECOS is a
Randomized, Placebo
Controlled Clinical Trial to
Evaluate Cardiovascular
Outcomes after Treatment
with Sitagliptin in Patients
with Type 2 Diabetes
Mellitus and Inadequate
Glycemic Control.
ClinicalTrials.gov
Identifier: NCT00790205
GUIDE-IT
In collaboration with DCRI
(Duke Clinical Research
Institute) GUIDE-IT is a
prospective, randomized
1:1, multi-centre clinical
trial GUIDing Evidence
Based Therapy Using
Biomarker Intensified
Treatment in Heart Failure
ClinicalTrials.gov
Identifier: NCT01685840
GUIDE-IT is just getting warmed up after the
summer months. The first Canadian site has
been activated and we look forward to the
first patient being enrolled momentarily with
many more to come! Congratulations to our first active site!
Dr. Patricia Campbell, Kim Ronak and
Sheilah Heal at University of Calgary/
Foothills Hospital in Calgary, Alberta.
Site Initiation Visits are complete and lab kits
have arrived on site, so with only a few site-
specific regulatory items outstanding we are
projecting that the remainder of our Canadian
sites will be ready to enroll within weeks. The
U.S. has enrolled over 80 patients and Canada
is eager to contribute to this number over the
coming months.
Protocol Amendment 1 has been distributed
and for those sites that are still in the ethics
review stages for this amendment, please re-
member that waivers for the revised patient
eligibility criteria are available if required.
The GUIDE-IT website is an invaluable re-
source for study documents and materials,
training and education items, study updates
and frequently asked questions. Please don’t be
shy about accessing this tool when needed!
Thank you to all of our GUIDE-IT sites for
your commitment to participate in this im-
portant heart failure study. We are looking
forward to working with each of you closely to
make this trial a success!
For further information, please contact Clinical
Trial Project Lead, Lyndsey Garritty at
1-800-707-9098, ext 4 or via email at
lyndsey.garritty@ualberta.ca.
Page 6 The Canadian Cardiac Chronicle
Monitoring
While we often cringe when we hear the word
“audit” cross our path, we have also come to
realize that with each audit we are involved in
we learn new things and become better at
what we do. We are always keen to share
these insights with you and hope that you can
implement some, if not all of them, into your
organizations now rather than when the
auditor dials up your number. Here are a few
tips to implement into your practice so you
are ready for that next audit:
Ensure all staff participating in the study at
your site are trained on (1) the protocol,
(2) any amendments, (3) GCP and Health
Canada Division 5, (4) transportation of
dangerous goods, (5) specimen collection,
and any other trial specific processes
prior to performing study procedures.
Ensure you have certificates and
documentation for each staff member
who will be working on the trial and make
sure that the trainer at your site is the
one documenting the topics of discussion
and not the trainee. All training should be
current.
In addition to having site SOP’s, for each
study that you participate in you should
have documented processes that are
specific for that trial. For example, if study
drug is required to be refrigerated, what
is your process once the drug is delivered
to your office, what is the process that
you will follow for temperature
excursions, and what is the process in the
event of a power outage? Other
processes can include things like where
are subjects going to be seen in the clinic,
and how will blood specimens be handled
and shipped.
Ensure you have calibration and
maintenance documentation of equipment
such as thermometers, blood pressure
machines, scales, ECG’s, centrifuge, etc.
Keep all records and make sure your
calibration and maintenance documents
are current.
Whether you work in a hospital or clinic
and have electronic medical records, you
should have validation documentation that
includes how often it is validated as well
as how and when the records are backed
up and stored.
CVC News
The CVC would like to welcome and
introduce you to our new team members:
Amanda Carapellucci
joined the CVC in
August to fill in as
Project Lead on the
EXSCEL trial during
Courtney Gubbels
maternity leave. Her
background includes a
BSc in Biological
Sciences and several
years of experience in research administration
and oncologic clinical trials.
Yvonne Regnier joined
CVC in August as
Dr. Armstrong's
Executive
Assistant. Yvonne has
extensive senior level
office administration
experience in both the
private and public
sector, as well as
diverse editorial experience in the research
arena in the Human Nutrition Research
Group at the University of Alberta.
Kalli Belseck joined the
CVC team back in
June, filling the role as
our Administrative
Assistant. She is a
recent graduate with a
BA, majoring in
Anthropology. Kalli is
becoming more
involved with the
clinical operations team and will be supporting
them on the trials with her initial focus on
PROACT, IMPROVE-IT and REGULATE PCI.
New Concepts in
Acute Coronary
Syndromes
Presenters:
• Paul Armstrong, MD
• Frans Van de Werf, MD
• Robert Welsh, MD
• Christopher Buller, MD
• Shaun Goodman, MD
• Valerie Desjardins, MD
• Darren McGuire, MD
• Justin Ezekowitz, MD
Agenda:
• The Future of ST
Elevation Myocardial
Infarction Care: One Size
Does Not Fit All
• The Need for Rescue
PCI After Failed
Fibrinolysis: Who, When
and Why?
• Modulating the
Oculogyric Reflex in
Acute Coronary
Syndromes: Insights from
a Veteran
• Triple Antithrombotic
Therapy in ACS:
Navigating the Quagmire
• Diabetes and Acute
Coronary Syndromes: An
Evidence-based Approach
• Acute Heart Failure –
ACS in Wolves’ Clothing?
Challenges and
Opportunities
• The Future of Clinical
Trials in ACS: More with
Less?
With monitoring related questions please
contact Lead CRA, Halina Nawrocki at 1-905-
896-7292 or by email at ha-
lina.nawrocki@rogers.com.
Page 7 Volume 17, No. 2
Selected CVC Presentations and Publications Since Last Issue
Leonardi S, Tricoci P, White HD, Armstrong PW,
Huang Z, Wallentin L, Aylward PE, Moliterno DJ,
Van de Werf F, Chen E, Providencia L, Nordrehaug
JE, Held C, Strony J, Rorick TL, Harrington RA,
Mahaffey KW. Effect of Vorapaxar on Myocardial
Infarction in the Thrombin Receptor Antagonist for
Clinical Event Reduction in Acute Coronary Syn-
drome (TRA•CER) Trial.Eur Heart J 2013; 34 (23):
1723-31. http://dx.doi.org/10.1093/eurheartj/eht104.
Rose JJ, Newby LK, Broderick S, Chiswell K, Van de
Werf F, Armstrong PW, Mahaffey KW, Harrington
RA, Ohman EM, Giugliano RP, Goodman SG,
White HD, Califf RM, Granger CB, Lopes RD. Left
bundle branch block in non-ST segment elevation
acute coronary syndromes: incidence, angiographic
characteristics and clinical outcomes. J Am Coll Cardi-
ol. 2013; 13: 1461–1463. http://dx.doi.org/10.1016/
j.jacc.2012.12.032 (Letter to Editor).
Guptill JT, Mehta RH, Armstrong PW. Horton J,
Laskowitz D, James S, Granger CB, Lopes RD.
Stroke After Primary Percutaneous Coronary Inter-
vention in Patients With ST-Segment Elevation My-
ocardial Infarction: Timing, Characteristics, and
Clinical Outcomes (APEX-AMI) Circ Cardiovasc In-
terv. 2013;6: 176-83. http://dx.doi.org/10.1161/
CIRCINTERVENTIONS.112.000159.
Lopes RD, White JA, Atar D, Keltai M, Kleiman NS,
White HD, Widimsky P, Zeymer U, Giugliano RP,
Tricoci P, Braunwald E, Bode C, Ohman EM, Arm-
strong PW, Newby LK. Incidence, treatment, and
outcomes of atrial fibrillation complicating non-ST-
segment elevation acute coronary syndromes. Int J
Cardiol. 2013 Apr 8. http://dx.doi.org/ 10.1016/
j.ijcard.2013.03.037 (online publication).
Klutstein MW, Westerhout CM, Armstrong PW,
Giugliano RP, Lewis BS, Gibson CM, Lutchmedial S,
Widimsky P, Steg PG, Dalby A, Zeymer U, Van de
Werf F, Harrington RA, Newby LK, Rao SV. Radial
versus femoral access, bleeding and ischemic events
in patients with non-ST-segment elevation acute
coronary syndrome managed with an invasive strat-
egy. Am Heart J. 2013 Apr;165(4):583-90. http://
dx.doi.org/10.1016/j.ahj.2013.01.009. Epub 2013 Feb
22.
Kaul P, Ezekowitz JA, Armstrong PW, Leung BK,
Savu A, Welsh RC, Quan H, Knudtson ML, McAl-
ister FA. Incidence of heart failure and mortality
after acute coronary syndromes. Am Heart J.
2013;165(3):379-85. http://dx.doi.org/10.1016/
j.ahj.2012.12.005.
van Diepen S, Newby LK, Lopes RD, Stebbins A,
Hasselblad V, James S, Roe MT, Ezekowitz JA,
Moliterno DJ, Neumann FJ, Reist C, Mahaffey KW,
Hochman JS, Hamm CW, Armstrong PW, Granger
CB, Theroux P; on behalf of the APEX AMI Investi-
gators. Prognostic relevance of baseline pro- and
anti-inflammatory markers in STEMI: An APEX
AMI substudy. Int J Cardiol. 2013 Feb 7. http://
dx.doi.org/10.1016/j.ijcard.2013.01.004 [Epub
ahead of print].
Tricoci P, Leonardi S, White J, White HD, Arm-
strong PW, Montalescot G, Giugliano RP, Gibson
CM, Van de Werf F, Califf RM, Harrington RA,
Braunwald E, Mahaffey KW, Newby LK. Cardiac
Troponin after Percutaneous Coronary Interven-
tion and 1-Year Mortality in NSTE ACS Using Sys-
tematic Evaluation of Biomarker Trends. J Am Coll
Cardiol. 2013; 62(3); 242–251. http://
dx.doi.org/10.1016/j.jacc.2013.04.043.
Lopes RD, Lokhnygina Y, Hasselblad V, Newby KL,
Yow E, Granger CB, Armstrong PW, Hochman JS,
Mills JS, Ruzyll W, Mahaffey KW. Methods of crea-
tine kinase-MB analysis to predict mortality in pa-
tients with myocardial infarction treated with
reperfusion therapy. Trials 2013, 14:123 epublica-
tion http://www.trialsjournal.com/
content/14/1/123; (PMID 23782531) http://
dx.doi.org/10.1186/1745-6215-14-123.
Nicolau JC, Corbalan R, Rafael Diaz R, Bahit C,
Armstrong PW, Granger CB, Lopes RD. Cardio-
vascular clinical research in South America. Am
Heart J 2013;165:848-53. http://dx.doi.org/10.1016/
j.ahj.2013.02.004.
Bahit MC, Lopes RD, Clare RM, Newby LK, Pieper
KS, Van de Werf F, Armstrong PW, Mahaffey KW,
Harrington RA, Diaz R, Ohman M, White HD,
James S, Granger CB. Heart Failure Complicating
Non–ST-Segment Elevation Acute Coronary Syn-
drome: Timing, Predictors, and Clinical Outcomes.
J Am Coll Cardiol HF 2013;1:223–9. http://
dx.doi.org/10.1016/j.jchf.2013.02.007.
Zannad F, Garcia AA, Anker SD, Armstrong PW,
Calvo G, Cleland JGF, Cohn JN, Dickstein K, Do-
manski MJ, Ekman I, Filippatos GS,Gheorghiade M,
Hernandez AF, Jaarsma T, Koglin J, Konstam M,
Kupfer S, Maggioni AP, Mebazaa A, Metra M,
Nowack C, Pieske B, Piña IL. Pocock SJ, Piotr Poni-
kowski P, Rosano G, Ruilope LM, Ruschitzka F,
Severin T, Solomon S, Stein K, Stockbridge NL,
Stough WG, Swedberg K, Tavazzi L, Voors AA,
Wasserman SM, Woehrle H, Zalewski A, McMur-
ray JJV. Clinical outcome endpoints in heart failure
trials: a European Society of Cardiology Heart
Failure Association consensus document. Eur J
Heart Fail. Epublication (PMID: 23787718) http://dx.doi.org/10.1093/eurjhf/hft095.
Alherbish A, Westerhout CM, Fu Y, White HD,
Granger CB, Wagner G, Armstrong PW. The For-
gotten Lead: Does aVR ST-deviation Add Insight
into the Outcomes of STEMI Patients? Am Heart J
If you have received
the chronicle
electronically and
would like a hard
copy, please email us
at:
thecvc@ualberta.ca
Address for Inquiries or
Submission of Articles of
Interest:
2-132 Li Ka Shing Centre for
Health Research Innovation
University of Alberta
Edmonton, AB T6G 2E1
Canada
Phone: 1-800-707-9098
Fax: (780) 492-0613
www.vigour.ualberta.ca
CANADIAN VIGOUR CENTRE
Page 8
Articles Continued...
Publication Information
This newsletter is published periodically as a service to Canadian investigational sites. The
purpose is to provide information of interest to individuals involved in cardiovascular clinical trials
managed by the Canadian VIGOUR Centre, University of Alberta in Edmonton, Alberta, Canada.
The VIGOUR (Virtual Coordinat-ing Centre for Global Collabora-tive Cardiovascular Research)
group is an international academic group committed to advancing cardiovascular medicine and enhancing patient care worldwide.
Its membership includes: the Canadian VIGOUR Centre (CVC), University of Alberta, Edmonton,
Alberta, Canada; Green Lane Coordinating Centre, Auckland, New Zealand; National Health &
Medical Research Council – Clinical Trials Centre, Sydney, Australia; Flinders Medical
Centre, Bedford Park, Australia; Duke Clinical Research Institute
(DCRI), Duke University, Durham,
NC, USA; Leuven Coordinating Centre, University Hospital Gasthuisberg, Leuven, Belgium; ECLA, Rosario, Argentina, South
America; TANGO, Buenos Aires, Argentina, South America; Uppsala Clinical Research Centre, Uppsala,
Sweden
Acknowledgments to our Sponsors:
Alere Inc.
Amylin Pharmaceuticals, LLC
GlaxoSmithKline Inc.
Hoffmann-La Roche
Merck & Co.,Inc. Regado Biosciences Inc.
Sanofi-aventis Recherche & Développement
Canadian Cardiac Chronicle Editorial Board:
PW Armstrong
Kalli Belseck
Courtney Bryden
Amanda Carapellucci
Robert Evans
Lyndsey Garritty
Halina Nawrocki
Jodi Parrotta
Dianne Payeur
Paula Priest
Tracy Temple
2013; 166: 333-9. (PMID: 2389517) http://
dx.doi.org/10.1016/j.ahj.2013.05.018.
Eapen ZJ, Reed SD, Li Y, Kociol RD, Armstrong
PW, Starling RC, McMurray JJ, Massie BM, Swed-
berg K, Ezekowitz JA, Fonarow GC, Teerlink JR,
Metra M, Whellan DJ, O’Connor CM, Califf RM,
Hernandez AF Do Countries or Hospitals With
Longer Hospital Stays for Acute Heart Failure
Have Lower Readmission Rates? Findings From
ASCEND-HF. Circ Heart Fail. 2013;6:727-732.
http://dx.doi.org/10.1161/
CIRCHEARTFAILURE.112.000265 ( Editor’s
Pick).
Roe MT, Goodman SG, Ohman EM, Stevens SR,
Hochman JS, Gottlieb S, Martinez F, Dalby AJ,
Boden WE, White HD, Prabhakaran D, Winters
KJ, Aylward PE, Bassand JP, McGuire DK, Ar-
dissino D, Fox KA, Armstrong PW. Elderly Pa-
tients with Acute Coronary Syndromes Managed
Without Revascularization: Insights into the Safe-
ty of Long-Term Dual Antiplatelet Therapy with
Reduced-Dose Prasugrel versus Standard-Dose
Clopidogrel. Circulation. 2013 2013;128:823-33.
(PMID: 23852610) http://dx.doi.org/10.1161/
CIRCULATIONAHA.113.002303.
Howlett JG, Ezekowitz JA, Podder M, Hernandez
AF, Diaz R, Dickstein K, Dunlap ME, Corbalán R.
Armstrong PW, Starling RC, O’Connor CM,
Califf RM, Fonarow GC; on behalf of the AS-
CEND-HF Investigators Global Variation in Qual-
ity of Care Among Patients Hospitalized With
Acute Heart Failure in an International Trial Find-
ings From the Acute Study Clinical Effectiveness
of Nesiritide in Decompensated Heart Failure
Trial (ASCEND-HF). Circ Cardiovasc Qual Out-
comes. 2013;6: on line publication http://
dx.doi.org/10.1161/
CIRCOUTCOMES.113.000119.
van Diepen S, Vavalle JP, Newby LK, Clare R,
Pieper KS, Ezekowitz JA, Hochman JS, Mahaffey
KW, Armstrong PW, Granger CB. The Systemic
Inflammatory Response Syndrome in Patients
With ST-Segment Elevation Myocardial Infarction.
Crit Care Med. 2013 Jun 11. [Epub ahead of print] PMID:23760155.
Wiviott SD, White HD, Ohman EM, Fox KAA,
Armstrong PW, Prabhakaran D, Hafley G, Lokh-
nygina Y, Boden WE, Hamm C, Clemmensen P,
Nicolau JC, Menozzi A, Ruzyllo W, Widimsky P,
Oto A, Leiva-Pons J, Pavlides G, Winters KJ, Roe MT, Bhatt DL. Prasugrel versus clopidogrel for
patients with unstable angina or non-ST-segment
elevation myocardial infarction with or without
angiography: a secondary, prespecified analysis of
the TRILOGY ACS trial. Lancet 2013;382:605-13
(PMID:23953385) http://dx.doi.org/10.1016/
S0140-6736(13)61451-8.
"Notice the outer ring of the compass is framed by
four phrases we believe capture the context of our work; (i) leading hearts and minds which links with our
logo of “bridging” hearts and minds, reflecting our
earnest efforts to provide thought leadership to
research so as to maximize its impact to
cardiovascular patients (ii) continuously innovating or
exploring new paths to enhance the care of our
patients but also finding new and better way of doing
things (iii) ensuring our work has impact on the
cardiovascular health and on health policy and (iv)
career development of our most valuable resource,
namely our people. Now working from inside the
compass, our purpose is central, and as equally well
known are CVC’s vision and core values, which were
the product of a prior Advance, and remain steadfast
and relevant today. The two new quadrants are
occupied by our promise which is what commitments
we aim to keep in fulfilling our purpose and finally
what operational priorities we propose moving
forward."
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