1. The Cardiovascular Inflammation Reduction Trial (CIRT)
Investigator and Coordinator Teleconference
November 22, 2013
Erin Cunniff
CIRT Project Coordinator
Aruna Pradhan, MD, MPH
Assistant Professor of Medicine, HMS
Director, Preventive Medicine Cohorts Biorepository, BWH

2. Agenda for Call Recruitment Overview – Aruna Pradhan, MD
Protocol Amendments – Aruna Pradhan, MD
Site Management – Erin Cunniff
Q and A

3. Recruitment Overview Sites Participants 368 Interested
274 with IRB approval
245 ready to screen
130 with 1+ participants screened
63 with 1+ participants randomized
Participants
654 Screened
212 Randomized (as of November 21, 2013)

4. Protocol Amendments
Qualifying Event has been expanded to include multivessel coronary disease
Qualifying white blood cell count (WBC) threshold has been lowered to 3,500

5. Qualifying Event: Current
Documented myocardial infarction within the past five years
The qualifying prior myocardial infarction must be documented either by hospital records OR by evidence on current ECG of Q waves in two contiguous leads AND/OR imaging test demonstrating wall motion abnormality or scar
The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.

6. Qualifying Event: New Eligibility Criteria
Documented myocardial infarction within the past five years
OR evidence of multivessel coronary artery disease by angiography in the past 5 years.

7. Additional Eligibility Criteria
Evidence of multivessel coronary artery disease by angiography in the past 5 years.
To qualify on the basis of multivessel coronary disease, there must be angiographic evidence within the past 5 years of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis

8. Qualifying Event
Which qualifying event is preferred in completing V1 eligibility criteria?
Myocardial Infarction
If the patient had an MI within 5 years, please collect and forward that documentation
The date of index event should be the date of MI
Multivessel coronary disease
If the patient has NOT had an MI within 5 years
The date of index event should be the date of the angiogram that demonstrated multivessel CAD

9. What documentation is required?
Myocardial infarction
Hospital discharge record
EKG with Q waves
Echo with scar or clear wall motion abnormality
Nuclear stress test showing scar or wall motion abnormality
Angiographic evidence of multivessel CAD
Cardiac catheterization report
Operative report (PCI or CABG)
Not Accepted: Coronary CTA

10. Protocol Change #2 Exclusion criteria NEW WBC exclusion criteria
Previously: WBC < 4,000/μL
NEW WBC exclusion criteria
WBC < 3,500/μL

11. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card

12. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card

13. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card

14. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card

15. Protocol Amendments Protocol Amendment BWH IRB CCC DSMB Next Steps
Copernicus
Local IRBs
IRB Services
EDC
System
Recruitment Materials
Manual of Operations
Quick Reference Card

16. Agenda for Call Recruitment Overview – Aruna Pradhan, MD
Protocol Amendments – Aruna Pradhan, MD
Study Drug Management – Erin Cunniff
Q and A

17. Study Drug Resupply
Study drug will expire in March new drug shipments have been initiated to all sites
Shipments are being processed in 2 phases
notifications are sent to sites before each shipment is sent
Fax the study drug acknowledgement form to BOTH the CIRT CC and Catalent
CIRT CC:
Catalent:

18. Study Drug Acknowledgement

19. Study Drug Resupply Return all study drug once new drug is received
Include Drug Shipment Return form in the box with the returned drug
The form can be found on theCIRT.org in Study Site Information in the CIRT Coordinating Center Forms section (PWD: CIRT2013)

20. Study Drug Resupply

21. Study Drug Resupply Return all study drug once new drug is received
Include Drug Shipment Return form in the box with the returned drug
The form can be found on theCIRT.org in Study Site Information in the CIRT Coordinating Center Forms section (PWD: CIRT2013)
to obtain a FedEx label

22. Study Drug Resupply

23. Study Drug Resupply Return all study drug once new drug is received
Include Drug Shipment Return form in the box with the returned drug
The form can be found on theCIRT.org in Study Site Information in the CIRT Coordinating Center Forms section (PWD: CIRT2013)
to obtain a FedEx label
Do not reissue unused calendar packs from old supply

24. Agenda for Call Recruitment Overview – Aruna Pradhan, MD
Protocol Amendments – Aruna Pradhan, MD
Site Management – Erin Cunniff
Q and A

25. Q & A
How do I assess my patient’s New York Heart Association (NYHA) heart failure class?
On the EDC page click the “help” link in the top right, which will give you the definition for each class of heart failure
Class I: No limitation of physical activity
Class II: Slight limitation of physical activity. Comfortable at rest but ordinary activity causes fatigue, shortness of breath
Class III: Marked limitation of physical activity. Comfortable at rest but less than ordinary activity causes fatigue or dyspnea
Class IV: Symptoms at rest. Unable to do any physical activity without worsening symptoms

26. Q & A Do I have to do the EKG at V4? Do I have to do the ABI?
What if my patient already takes folic acid?
Do I distribute randomized drug in the same way I distribute run-in calendar packs?
What if a patient arrives for a visit and the CRF has not appeared in the EDC yet?