Operational DetailsPamela K. Woodard, M.D.

Agenda

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

CASE REIMBURSEMENT

•CCTA - $1500• SPECT- $1000

CASE REIMBURSEMENT

Enrollment CCTA/SPECT Completion of 6 &

12 month follow-up forms Why? Triggers

chart abstraction needed to confirm outcomes and to do cost analysis.

RA Involvement

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).

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

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).

Accrual Goals

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

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.

Patient Flow

Phase 1• Screening checklist

Inclusion/Exclusion Criteria• Informed consent

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.

Records Release

“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.”

Excerpted from the informed consent

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).

Patient FlowPhase 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.)

Patient Flow

Phase 4• Make sure referring has copy of CCTA/SPECT

report and OMT handout and is aware of RESCUE study design.

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.)

What is OMT?• An antiplatelet such as aspirin or clopidogrel, if participant is aspirin

intolerant.

• A statin with target LDL cholesterol of 60 to 85 mg/dL.

• An anti-hypertensive/anti-anginal beta-blocker with 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.

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.

OMT

• Based on recommendations of COURAGE Trial.

• Web-based resources for physicians and patients under development.Smoking cessation.Diet modification.