Scientific Publications by FDA Staff

Am Heart J 2012 Dec;164(6):846-55

Cardiac imaging approaches to evaluate drug-induced myocardial dysfunction.

Christian JB, Finkle JK, Ky B, Douglas PS, Gutstein DE, Hockings PD, Lainee P, Lenihan DJ, Mason JW, Sager PT, Todaro TG, Hicks KA, Kane RC, Ko HS, Lindenfeld J, Michelson EL, Milligan J, Munley JY, Raichlen JS, Shahlaee A, Strnadova C, Ye B, Turner JR

The ability to make informed benefit-risk assessments for potentially cardiotoxic new compounds is of considerable interest and importance at the public health, drug development, and individual patient levels. Cardiac imaging approaches in the evaluation of drug-induced myocardial dysfunction will likely play an increasing role. However, the optimal choice of myocardial imaging modality and the recommended frequency of monitoring are undefined. These decisions are complicated by the array of imaging techniques, which have varying sensitivities, specificities, availabilities, local expertise, safety, and costs, and by the variable time-course of tissue damage, functional myocardial depression, or recovery of function. This White Paper summarizes scientific discussions of members of the Cardiac Safety Research Consortium on the main factors to consider when selecting nonclinical and clinical cardiac function imaging techniques in drug development. We focus on 3 commonly used imaging modalities in the evaluation of cardiac function: echocardiography, magnetic resonance imaging, and radionuclide (nuclear) imaging and highlight areas for future research.