Current Evidence and Lessons Learned from Randomized Trials in Cardiovascular Imaging. Chapter 9

Cardiovascular disease imparts a heavy financial burden and impacts the lives of millions of patients around the world, leading to loss of societal productivity coupled with premature morbidity and mortality. For imaging to contribute to a healthier patient population, new standards require a demonstrable impact on important clinical outcomes. This chapter highlights the rationale for employing clinical trials in cardiovascular imaging and provide recent examples of net health benefit resulting from non‑invasive strategies of cardiovascular care in published literature. Although in decades past, the available clinical trial evidence was less developed, currently there is robust evidence that the use of cardiovascular imaging can guide clinical management decisions and, in some cases, improve clinical outcomes. Preceding a discussion of available clinical trials, some guidelines will be described as to evidentiary standards applied in cardiovascular imaging and the hierarchy of quality for evaluating clinical trials and registries. This will be followed by a description of how evidence standards evolve and makes the transition from observational findings to impacting patient outcome. Finally, an overview of existing clinical trials and how they contribute to devising appropriate indications for cardiovascular imaging and guided therapeutic strategies of care will be presented.