Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : Well Established Methods for Imaging Approaches, IVUS and IMT (Wolfgang KOENIG)

MODIGLIANI Workshop 2 - Friday November 30, 2012 :ATHEROSCLEROSIS IMAGING IN CLINICAL TRIALSFacilitating the discovery of effective therapiesChairpersons: Jagat NARULA, New York, USA - Ahmed TAWAKOL, Boston, USAWebcast: Bart STAELS, Lille, FRAPhase III clinical endpoint trials evaluating treatments for atherosclerosis typically require very large sample sizes, cost hundreds of millions of dollars and historically have had very low success rates. As a result, few new therapies that attenuate the progression of atherosclerosis have been identified in over 30 years (since the discovery of statins). Nearly a decade ago, in recognition of the low success of Phase III trials, regulatory agencies called for the adoption of new biomarkers or surrogate endpoints to enhance the rate of clinical development. To that end, several cardiovascular imaging technologies have gone through evolutionary cycles of validation over the past decade and several have demonstrated promise as clinical tools and as clinical trial biomarkers.With the rapid development and implementation of these imaging approaches, it is important to delineate the opportunities and limitations associated with these tools. In particular, it is essential to identify imaging biomarkers that might accurately predict eventual clinical success based on the observed changes in the atherosclerotic imaging measurements. With such tools as gatekeepers, only those treatments with proven efficacy during Phase II trials would be promoted to Phase IIIwith the expectation of high likelihood of success in the clinical endpoint trials. By enhancing the success rate of Phase III clinical trials, use of these imaging tools have the potential to accelerate the discovery of treatments for atherosclerosis.Session program:Overview: Why are imaging endpoints needed in CV clinical trialsSpeaker: Jagat NARULA, New York, USAWell Established Methods for Imaging Approaches: IVUS and IMTSpeaker: Jean-Claude TARDIF, Montréal, CANDiscussant: Wolfgang KOENIG, Ulm, GERCoronary CTA in clinical trialsSpeaker: Udo HOFFMANN, Boston, USAMRI imaging in clinical trialsSpeaker: Zahi FAYAD, New York, USADiscussant: Robin CHOUDHURY, Oxford, GBRPET-CT imaging in clinical trialsSpeaker: Ahmed TAWAKOL, Boston, USADiscussant: James RUDD, Cambridge, GBR