Operational Details

1. Operational Details Pamela K. Woodard, M.D.

2. Agenda • Reimbursement • Site Requirements • Timeline to start up • Recruitment goals • Patient flow • Consent form • What constitutes OMT?

3. CASE REIMBURSEMENT • CCTA - $1500 • SPECT- $1000

4. CASE REIMBURSEMENT RA Involvement • Enrollment • CCTA/SPECT • Completion of 6 & 12 month follow-up forms Why? Triggers • chart abstraction needed to confirm outcomes and to do cost analysis.

5. Site Requirements • Ability to start recruitment in December (RESCUE funds are ARRA funds). • Current availability of Research Coordinator. • Ability to recruit 2 stable angina chest pain patients/ week. • Implementation of TRIAD software and submission of test CCTA and SPECT examination data (2 CCTAs and 2 SPECTS each). Will be reviewed by RESCUE technical staff. • Strong, interactive relationship between radiology and cardiology. • Willingness of referring cardiologists to agree to the RESCUE schema (familiarity and willingness to provide a trial of OMT in patients with CAD but without left main disease).

6. Timeline • NGA – September 28, 2010 • Site Preparation – Oct-Dec 2010 • Activation – December, 2010 • Accrual – Dec – May, 2012 (18 months) • 12 month f/u – Dec, 2011 – May, 2013 • Database closure/analysis – June-Sept, 2013

7. Countdown to Activation 1. ACRIN General Qualifying Application/Protocol Specific Application (GQA/PSA) • If PROMISE site, will need to provide a short plan for equitable recruitment for both studies. • 2 patient de-identified image sets per modality (CCTA/SPECT) w/completion of practice CRF. 2. ACRIN-Institutional Agreement (Contract) 3. Local IRB – Each site must obtain IRB approval locally. 4. TRIAD III Installation 5. SPECT/CCTA Reader Certification – (Easy: Attestation of LEVEL II/Minimum ACR via letter).

8. Accrual Goals • 4300 patients • Recruitment: 18 months or less • 60-80 sites – staggered start-up • 2 per week per site

9. Sources for Patient Recruitment • Outpatient cardiology Physicians willing to treat all disease but left main with a trial of OMT. • Internists/Family Practice • ED observation unit Exertional angina, recurrent chest pain, troponins negative, NO IMAGING.

10. Patient Flow Phase 1 • Screening checklist • Inclusion/Exclusion Criteria • Informed consent

11. Records Release Depending on how you respond to questions the research staff asks you about your heart and other health and treatment, your medical record information will be collected from your treating doctors. This might mean information is collected from institutions other than this one. All information that might identify you as the patient will be removed and this “de-identified” information will be sent to an authorized representative to be reviewed and coded.

12. Records Release Excerpted from the informed consent “You further understand and agree that authorized representatives of ACRIN, the FDA, AHRQ and its agents and contractors, the Institutional Review Board (IRB) of <<Institution>> and other groups or organizations that have a role in this study may, without obtaining additional consent from you, have access to and copy both your medical and research records, including the results of your participation in this study. This access is necessary to ensure the accuracy of the findings, the completion of the study, and your safety and welfare. If any publication or presentations result form this study, you will not be identified by name. Results will be reported in a summarized manner in which you cannot be identified.”

13. Patient Flow Phase 1 • Screening/informed consent. • Complete Medical Hx, Risk Factor and other baseline CRFs (CCS, SAQ, SF-36) to include patient contact information. • Serum creatinine (if necessary, may be performed at Phase 3). • Pregnancy test (if necessary, may be performed at Phase 3, just prior to CCTA or SPECT).

14. Patient Flow Phase 2 • ACRIN Web based registration • randomization SPECT vs. CCTA • CCTA or SPECT scheduled Phase 3 • SPECT or CCTA Performed • Record AEs for CCTA (CCTA is the research study, not SPECT since it is SOC.)

15. Patient Flow Phase 4 • Make sure referring has copy of CCTA/SPECT report and OMT handout and is aware of RESCUE study design.

16. Patient Flow FOLLOW UP (6, 12, 18 months . . . Possibly 24) • Complete follow-up CRFs (queries regarding MI, cath, hospitalization and whether taking their meds). • If patient received CV healthcare, get name and address of where treated and medical records will be obtained and de-identified by ACRIN for chart abstraction. • (SAQ, SF-36 mailed to patient directly from ACRIN at 12 mos.)

17. What is OMT? • An antiplatelet such as aspirinor clopidogrel, if participant is aspirin intolerant. • A statin with target LDL cholesterol of 60 to 85 mg/dL. • An anti-hypertensive/anti-anginal beta-blockerwith BP goal of < 130/80 mmHg, and reduced CCS angina class. • An additional anti-hypertensive, such as, amlodipine or ACE-inhibitor, as needed. • An additional anti-anginal, as needed.

18. What is OMT? • An ACE inhibitor or angiotensin II receptor antagonist if ACE inhibitor not tolerated, for all patients with LV EF < 40%. • Attempt to raise HDL cholesterol above 40 mg/dL with exercise, extended release niacin, or fibrates alone or in combination, once LDL is at goal. • Medications for diabetes control, with target HbA1c < 7%. • Smoking cessation. • Exercise regimen appropriate to diagnosis. • Nutritional/dietary modification.

19. OMT • Based on recommendations of COURAGE Trial. • Web-based resources for physicians and patients under development. • Smoking cessation. • Diet modification.