patient recovery after robotic assisted vs. traditional cabg 1) a comparative effectiveness trial of...

Patient Recovery After Robotic Assisted vs. Traditional CABG

1) A Comparative Effectiveness Trial of Exercise Tolerance (CPX) after Surgery

2) Multicenter Registry to Document Early QOL and time to return to work

CASE REPORT FORMS

www.smartsmsmarketing.com

CONTACT INFORMATION

Univ of Chicago Pranjal Desai

drpranjaldesai@gmail.com Robert Postonpostonlab@gmail.comCell 617-610-0126

Gary Balady

Univ of Toledo Jena.Donovan@utoledo.edu; contract andria.powell@utoledo.edu

419-383-6915

Thomas SchwannThomas.Schwann@utoledo.edu

419 383-5150 office860 841-8258 cell

Dr. Badenhopdalynn.badenhop@utoledo.edu

Lennox Hill Joan Jenningsjjennings@lenoxhill.net

Nirav PatelNIPatel@LENOXHILL.NET

Univ of Maryland Johannes Bonattijbonatti@smail.umaryland

.edu4438349124

Aldo Iaconoaiacono@umaryland.edu

Intuitive Cyprian OkaforLegal representative

Myriam Curet

Center for Clinical Trials (CCT)

U Maryland

D MurrayDmurr002@umaryland.edu410-706-5638Jeanne Galvin-Clarkejclarke@umaryland.edu

Tessie Langreo billing analysis and budget, tlangreo@umaryland.edu

STUDY SITE STUDY COORDINATORS SURGEON-PI CPX TESTING MD

Site ID#Univ of Maryland: UMUniv of Toledo: UTLennox Hill: LHUniv of Chicago: UCSam Balkey: SBSt. Joseph’s: SJLankenau Hospital: LH

Patient ID#Univ of Toledo: numbers will range from 1-70

Univ of Maryland, Good Samaritan, Lennox Hill,Univ of Chicago: numbers for CPX study will range from 1-20

All registry participants: numbers will range from 1-100

Study subject ID: Site ID# - Patient ID# (e.g. UM-04)

*Zipcode very important to estimate income

*For CPX studyData not part of the STS requirement

*For CPX and registryBased on phone interview at 1 yearData not part of the STS requirement

• For CPX and Registry• Data not part of the STS requirement

Collection of flow tracing

*CPX study and registry: Electonic file to be downloaded onlineData not part of the STS requirement

Collection of Cerebral Oximetry Tracings

*For CPX and Registry participants that use cerebral oximetryData not part of the STS requirement

Intubation billateral IMA harvesting LIMA to LAD grafting RIMA to OM grafting

Cerebral desaturation

*For CPX study and registry: obtained by interview at 3 weeksData not part of the STS requirement

*For CPX study and registry: obtained by interview at 3 weeksData not part of the STS requirement

*For Registry and CPX Data not part of the STS requirement

*For CPX study onlyData not part of the STS requirementBiomarker values will be entered by core lab – serum samples sent by study sites

INTRAOPERATIVE GRAFT DATA CT SCAN results

Type of Conduit (LIMA, SVG…)

Coronary target (LAD, OM…)

Estimated Conduit Diameter(mm)

Estimated Target Diameter(mm)

Target Quality(Good/poor)

Regional WMA (y/n)

Graft Flow (cc/min) PI %DF

Patent at 1 Week (y/n/not done)

Patent at 6 Mo (y/n/not done)

*For CPX and registryData not part of the STS requirement

*For CPX study onlyData not part of the STS requirement

Collection of perioperative serum samples

Copyright ©2009 American Heart Association

Myers, J. et al. Circulation 2009;119:3144-3161

Exercise Testing – Pre and Postop

Copyright ©2009 American Heart Association

Myers, J. et al. Circulation 2009;119:3144-3161

Copyright ©2009 American Heart Association

Myers, J. et al. Circulation 2009;119:3144-3161

RIMA

LIMA

LAD OM1

Follow-up CT angiography – 6 months