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Title International Study of Comparative Health Effectiveness with Medical and Invasive Approaches
Year 2010
Contributor/Contact David Maron, Daniel Bryne, Frank Harrell, Terri Scott
CTSA Vanderbilt
Success Topic Collaboration, Direct clinical impact, Grants
Description of Success Herein is a BERD Success Story from design, planning, and implementation of a survey to determine if a clinical trial strategy would be acceptable to practitioners, to the design, planning, and implementation of an $84M multicenter clinical trial to assess the role of cardiac catheterization and revascularization in the initial management of stable ischemic heart disease (SIHD) patients with extensive ischemia.

It is unknown whether strongly held beliefs regarding the need for cardiac catheterization and revascularization in SIHD patients would preclude a study randomizing patients with significant ischemia to an initial conservative strategy without cardiac catheterization. In order to answer this question, the DBRE helped Vanderbilt cardiologist David Maron design and implement a multinational survey of cardiologists.

Development of this survey (and ultimately design of a multinational clinical trial) utilized most of Vanderbilt Institution for Clinical and Translational Research (VICTR) Design Biostatistics and Research Ethics (DBRE) programís resources: clinics, Studios, vouchers, REDCap expertise, and the expertise of many members of VICTR and other faculty in the Department of Biostatistics. The collaboration began with consideration of whether cardiologists would allow the intended patient population to be randomized. Dan Byrne, Terri Scott, and Frank Harrell worked intensively with Dr Maron to design a REDCap survey to be posted on websites of the American College of Cardiology Foundation and TCTMD.

This online survey queried cardiologistsí willingness to enroll a sample patient with frequent stable angina, >10% myocardial ischemia, and normal ejection fraction into a randomized trial with a 50% chance of being conservatively managed without cardiac catheterization. Among 499 respondents, 57% (95%CI: 53-62%) were willing to enroll the patient. Among 207 cardiologists not willing to enroll, 55% (95%CI: 48-61%) would do so if the patient would be excluded based on high-risk features from on stress imaging, yielding a total of 80% (95%CI: 76-83%) willing to enroll. No differences were observed among different types of cardiologists (interventional, invasive/non-interventional, and noninvasive).

These findings were used as part of the preliminary data that was submitted in the grant application for the randomized controlled trial. NHLBI decided to award the grant, which will test the hypothesis that in patients with moderate-to-severe ischemia on stress imaging, a routine early invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy is superior to a conservative strategy of optimal medical therapy, with catheterization and revascularization reserved for those with a primary endpoint event or refractory symptoms. The Study Chair is Dr. Judith Hochman, NYU cardiologist and Co-Executive Director of the NYU Clinical and Translational Science Institute. Dr. Maron is the Principal Investigator and Study Co-Chair. Dr Harrell will head the Statistics Committee and the statistical analysis center for the DSMB of the study. The name of the trial isISCHEMIA: International Study of Comparative Health Effectiveness with Medical and Invasive Approaches.

During the CTSA-sponsored collaboration, the team examined many aspects of study design including dealing with crossovers, multiple endpoints, Bayesian sequential design, Bayesian inference, sizing the study for precision, and frequentist group sequential monitoring.
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Published_BERD_Watch Vanderbilt Advances Comparative Effectiveness Trial
Additional Information ISCHEMIA Trial Release Information
Disclaimer The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.
Topic revision: r10 - 21 Jun 2012 - 13:24:05 - MaryBanach

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