Novel non-invasive imaging tests have been developed to characterize atherosclerotic plaque burden and metabolic activity (inflammation). However, the value of these atherosclerosis imaging technologies for predicting coronary heart disease (CHD) and stroke events has not been evaluated in prospective studies. Proposed is a study to conduct noninvasive imaging and longitudinal follow-up in a high risk cohort of patients with diabetes by utilizing the recruitment network, events follow-up protocol and adjudication committee assembled by the NHLBI-sponsored FREEDOM Trial (Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease - HL071988).
Specific aims of our study are (1) to determine the association of atherosclerotic plaque burden and the risk of CHD and stroke events and all cause-mortality;(2) to determine the association between traditional CHD risk factors and atherosclerotic plaque burden;and (3) to determine the association between plaque burden and plaque inflammation. In order to accomplish these aims, we will recruit 380 diabetic patients with multi-vessel coronary disease from eleven greater New York metropolitan area hospitals. Patients will complete a baseline study visit at Mount Sinai School of Medicine (MSSM) to assess plaque burden and plaque inflammation by magnetic resonance (MR) (contrast and non contrast) and fluorodeoxyglucose (FDG)-positron emission tomography (PET) imaging. Additionally, questionnaires will be administered, a physical examination conducted and blood specimens collected to measure hemostatic and inflammatory markers. Patients will be actively followed for 36 months through annual in-person study visits and bi-annual telephone follow-up. When events (mortality, non-fatal MI and non-fatal stroke) are identified, hospital charts and death certificates will be reviewed by an adjudications committee, blinded to the baseline measurement values. Changes in plaque burden and inflammation will be assessed through MR and FDG-PET imaging, respectively, at the 36 month follow-up visit again at MSSM. The proposed study will provide the unique opportunity to assess atherosclerotic plaque burden as a predictor for clinical events in a high risk patient cohort. Data from this study will not only advance our understanding of the aggressive atherosclerotic process associated with diabetes but will also provide us with a strategy to combine novel noninvasive approaches to better follow the effects of medical and revascularization therapy in the diabetic patient. It is our expectation that data from the proposed study will be utilized to evaluate and improve existing treatment and help guide the development of effective new therapies aimed at reducing CHD and stroke events and improving survival in high risk diabetic patients.
The FREEDOM Imaging study aims to determine the prospective association of atherosclerotic plaque burden, assessed through non-invasive MRI, and clinical events in high risk patients with diabetes mellitus. Data from the FREEDOM Imaging study will not only advance our understanding of the aggressive atherosclerotic process associated with diabetes, but will also provide us with a strategy to combine novel tools to better follow the effects of medical and revascularization therapy in the diabetic patient. It is our expectation that our data will be utilized to evaluate and improve existent treatment and develop effective new therapies to decrease the burden of atherosclerotic disease in diabetes.
