Imaging as an End Point in Ischemia Trials

Imaging as an End Point in Ischemia Trials

Imaging of cardiac function and anatomy has advanced at an exponential rate over the past two decades. Our ability to quantitatively assess the degree of myocardial ischemia and accurately define the vascular anatomy using noninvasive techniques is greater than ever before. Current advances is cardiac imaging are allowing us to more safely assess patients for myocardial ischemia and better unde...

Arterial stiffness as surrogate end point: needed clinical trials.

Classic risk scores may underestimate the risk of cardiovascular (CV) events in specific risk groups suitable for primary prevention, such as asymptomatic hypertensive subjects. Particularly, those considered as at intermediate risk may benefit the most from a reassessment of their CV risk using novel biomarkers. In primary prevention, some imaging biomarkers, such as arterial stiffness, enhanc...

Expediting MRI-based proof-of-concept stroke trials using an earlier imaging end point.

BACKGROUND AND PURPOSE Before Phase III trials of acute stroke therapies, proof-of-concept MRI trials are increasingly used to gauge the likelihood of success. Given that animal models use infarct volume as the end point, Phase II trials have aimed to translate the findings using infarct growth. These trials could be expedited if subacute diffusion-weighted imaging lesion volume replaced late T...

Use of B mode ultrasound of peripheral arteries as an end point in clinical trials.

Computed tomography coronary plaque imaging as a secondary end point for randomized pharmaceutical trials: more bang for the buck?

In a perfect world for the cardiovascular computed tomography (CT) researcher, quantitative assessment of coronary atherosclerotic plaque using CT angiography (CTA) has been validated as a surrogate end point for major cardiovascular events and is used to prove the efficacy and efficiency of new drugs in a very cost-effective manner within a viable framework provided by the US Food and Drug Adm...