Clinical Trials

Mount Sinai coordinates and participates in many multicenter trials and has a long history of key involvement in landmark clinical investigation. We have participated in the leading trials in cardiovascular medicine.

The Mount Sinai Clinical Trials Unit, directed by Dr. Michael Farkouh, coordinates numerous international and local trials. Mount Sinai is the international Clinical Coordinating Center for the NHLBI-sponsored FREEDOM Trial. Dr. Fuster is the Principal Investigator of this large outcomes trial comparing percutaneous coronary intervention (PCI) using drug-eluting stents to coronary artery bypass surgery in diabetic patients with multivessel disease. Numerous ancillary studies are being conducted under the FREEDOM network umbrella and this program serves as a unique opportunity for fellows to work on cutting-edge research.

The Clinical Trials Unit also directs the Grenada Heart Project in collaboration with the World Heart Federation. This five-year cohort study will survey 5,000 individuals on the island of Grenada to characterize the cardiovascular risk factor burden in this developing country and to implement a culturally tailored public health intervention plan. This demonstration project aims to develop a model which can be extended to other developing economies.

Mount Sinai has historically been associated with atherothrombosis research. After animal models of lipid deposition demonstrated plaque regression with high dose "statins" (histology and MRI), a human trial here showed analogous results for the first time in human subjects. In collaboration with the Cardiovascular Imaging Laboratories, our group is exploring the research paradigm of using imaging as a surrogate endpoint in clinical trials of atherosclerosis. Mount Sinai serves as the core laboratory for many multicenter studies evaluating novel compounds in development to treat atherosclerosis using multimodality imaging (MRI-PET). Other areas of research utilizing imaging include evaluation of infarct size using MRI and chest pain risk-stratification studies using CT angiography. This area of research will be expanded in our new imaging center in the Atran Building.

Research carried out by the Thrombosis Research Laboratories is truly translational in its overlap between the clinical and basic science arenas. Tools developed at Mount Sinai for thrombus formation (the Badimon chamber: native blood flowing over aortic tunica media) and platelet function have played key roles in furthering our understanding of atherothrombosis. Studies conducted through this laboratory have examined platelets in patients with coronary artery disease and depression, the effect of estrogen replacement on thrombus formation in postmenopausal women (now made obsolete as a long-term treatment strategy by large clinical studies) and thrombogenicity of blood in patients whose lipids were lowered. In each of these studies, there was an intimate collaboration between the clinical side (patient recruitment, study design) and the basic laboratory (providing assessment of biologic endpoints).

The Clinical Trials Unit provides support as a coordinating center to other subdivisions with the Cardiovascular Institute such as the Cardiac Catheterization Laboratory (ABCD-PCI study, interventional database) and the Electrophysiology Laboratory (FREEDOM St. Jude's).

Key investigators have played a pivotal role in major international clinical studies. Dr. Farkouh led the cardiovascular outcomes committee of the 18,000-patient TARGET trial evaluating the role of COX-2 inhibitors and traditional non-steroidal anti-inflammatory drugs from Mount Sinai. Dr. Jonathan Halperin spearheaded the Stroke Prevention in Atrial Fibrillation (SPAF) NIH trial and international investigation of the use of ximelagatran, an oral thrombin inhibitor, in atrial fibrillation and venous thromboembolism (SPORTIF series of studies). In the past, Mount Sinai has participated in many clinical trials, including GUSTO I, II and III, CARS (Coumadin Aspirin Reinfarction Study), and PURSUIT, to name a few. Several important sub-studies of these trials have been organized at Mount Sinai. These sub-studies and the databases associated with these large studies afford fellows opportunities for individual investigation within the main trial.

Outcomes Research and Clinical Practice Evaluation

Several projects are underway to assess and improve clinical practices and patient outcomes in Cardiovascular Medicine. In close collaboration with the Department of Health Policy, we developed evidence-based guidelines for the acute hospital care of patients with acute myocardial infarction. Application of these guidelines will form the basis of a clinical quality improvement project that encompasses not only The Mount Sinai Health System, but also the rapidly growing Mount Sinai Consortium of affiliated institutions and medical practices throughout the New York metropolitan area. Other areas of active investigation include the assessment and improvement of the current practice of lipid management in patients undergoing coronary revascularization, the evaluation of patient-reported functional status following percutaneous coronary revascularization, the impact of physician specialty and payor status on clinical outcomes in patients with cardiovascular disease, the development of new strategies to maximize functional independence in elderly people with heart failure and the development of algorithms to treat diabetic patients both in the hospital and in the community. Future studies, in collaboration with the Department of Emergency Medicine will focus on characterizing, developing treatment strategies for, and assessing the outcomes of patients cared for in Mount Sinai's short-stay chest pain evaluation unit.

Education

Icahn School of Medicine offers a one-year Clinical Research Training Program (CRTP) or two-year courses leading to master's degrees in Clinical Research (MS) or Public Health (MPH). Fellows are encouraged to pursue these courses dedicated to clinical research. The Clinical Trials Unit partners with the Institute of Epidemiology, Biostatistics and Prevention to provide fellows with instruction in clinical research methodology and biostatistics.