The Cardiovascular Clinical Research Center was established in 2003 under the direction of Judith S. Hochman, MD, the Harold Snyder Family Professor of Cardiology. The center facilitates all aspects of cardiovascular patient–based clinical research and education, including coordination of multicenter, randomized clinical trials and registries; support of the infrastructure for clinical research; and education of faculty, fellows, and junior trainees in clinical research methodology. Center personnel include cardiology investigators, grant managers, project managers, research coordinators, and project support staff.

Our scientists lead clinical trials in ischemic heart disease, women’s heart disease, takotsubo syndrome, cardiogenic shock, rhythm disorders, cardiovascular ultrasound, noninvasive cardiology, heart failure, patient outcomes, platelet activity and antithrombotic therapy, chelation therapy, geriatric cardiology, and adult congenital heart disease. We are currently conducting NYU Langone’s Rehabilitation at Home Using Mobile Health in Older Adults After Hospitalization for Ischemic Heart Disease trial, also known as RESILIENT, to evaluate the effectiveness of cardiac rehabilitation being administered through a mobile health application.

Notably, our researchers were awarded an $84 million grant from the National Institutes of Health (NIH) for the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) and ISCHEMIA–Chronic Kidney Disease (CKD) trials. This is the largest NIH grant ever received at NYU Langone.

Our researchers have also led a number of international multicenter, randomized clinical trials, including the Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock (SHOCK) trial, the SHOCK-2 phase II trial, and the Tilarginine Acetate Injection in a Randomized International Study in Unstable MI Patients with Cardiogenic Shock (TRIUMPH) phase III trial. These National Heart, Lung, and Blood Institute (NHLBI) Small Business Innovation Research program–funded trials were the first to test a novel pharmacologic agent for refractory cardiogenic shock.

Another large international multicenter trial, the Occluded Artery Trial (OAT), which was funded by the NHLBI and led by Dr. Hochman, was organized by the Clinical Coordinating Center, within the Cardiovascular Clinical Research Center.

The SHOCK trials and OAT resulted in new recommendations published by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology.

Clinical Coordinating Center

Since its inception, the Clinical Coordinating Center within the Cardiovascular Clinical Research Center has coordinated numerous investigator-initiated and multicenter cardiovascular clinical trials at NYU Langone and affiliates, throughout the United States and around the world.

Dr. Hochman directs the Clinical Coordinating Center, with Harmony R. Reynolds, MD, serving as associate director. The center works closely with all parties; our team is accessible 24 hours a day, 365 days a year. We facilitate communication with the NHLBI and other sponsors, the NYU Statistical and Data Coordinating Center, core laboratories, and clinical sites.

Our center is the primary day-to-day contact for all cardiovascular clinical trial sites. Our staff develop and implement educational and training plans, as well as communication initiatives such as phone and email contact, conference calls, newsletters, and web-related functions. Our staff also collaborates with sites to ensure their understanding and execution of protocols and successful identification of eligible patients for screening and enrollment.

Our aim is to vet sites for interest and capabilities, provide extensive education to researchers at the sites, and carefully and clearly state what is expected of the sites in order to minimize problems with performance. When site problems arise that cannot be handled by email or phone, the center coordinates with Statistical and Data Coordinating Center staff to conduct site visits together.

Our center is responsible for the following additional aspects of clinical trials.

Clinical Operations

Clinical operations at the center include the following:

• development of the protocol, manuals of operations, standard operating procedures, consent requirements, and all amendments
• monitoring of study progress
• quality control
• leadership of data analysis, presentations, and publications
• oversight of core laboratories

Site Management

Site management includes:

• identification and start-up
• monitoring
• reimbursement

Personnel

The center provides the following personnel support:

• assistance in the hiring of qualified study personnel
• certification of personnel
• study staff training
• recruitment, education, and retention
• staffing of a 24-hour help line to answer questions from clinical sites

Administrative

Administrative support includes:

• assembly of administrative components and coordination of the entire grant submission
• oversight of all committees and working groups
• budget development and review

Regulatory Assistance

The center also offers regulatory assistance, including:

• oversight of all institutional and federal regulatory submissions required for the conduct of a clinical trial
• maintenance of regulatory documents

Other Resources for Large, Multicenter Clinical Studies

NYU Langone offers other resources for large, multicenter trials. The Center for Large Scale Clinical Studies provides support to investigators, as both a clinical trial center and a statistical and data-coordinating center, in the development and implementation of large-scale multisite studies, largely NIH funded.

DataCore provides additional support for multisite and single-site studies, including electronic data capture and storage, database design, and data management and analysis.