Cardiac surgery has been a spectacularly innovative field of medicine. The introduction of major innovations and ongoing incremental change have extended survival and improved quality of life for many patients suffering from cardiac disease. A rapid pace of innovation requires a rigorous infrastructure for clinical evaluation that provides timely assessments of the value of new treatments. The NHLBI, in collaboration with NINDS and CIHR, created the Cardiothoracic Surgical Trials Network (CTSN) to provide such an infrastructure. InCHOIR enthusiastically embraces the unique opportunity to work in partnership with the sponsors and clinical investigators as the CTSN DCC. Given our long-standing interest and experience in the design and analysis of cardiac surgery multicenter studies, we offer strong expertise to support clinical and scientific coordination, communication, logistical, and administrative functions necessary to promote this vital clinical research effort. The CTSN faces important challenges in designing and implementing trials, including the need to develop scientifically rigorous and feasible trials for evaluating surgical treatments for patients with cardiac disease that will serve as, and will be uniformly accepted as, the basis for treatment decisions. To meet these challenges we will provide leadership in the design of innovative exploratory clinical trials, exploiting our experience in designing novel clinical trials addressin specific needs not met by """"""""off the shelf"""""""" designs;establish uniform outcome definitions;a web-based database for the collection and management of trial data and sharing of data among all investigators;training and monitoring of the clinical sites and core laboratories;clinical coordination, data management and quality assurance;administrative skills and the necessary leadership. We will promote the CTSN research objectives by facilitating the publication process, presenting at meetings and by developing an easily navigable public and private study informational website that provides important and timely information to the research community, practicing clinicians, and patients.

Public Health Relevance

Clinical trials are a critical step in translating discoveries into better treatments for people burdened by cardiac disorders. Such trials typically require cooperation and coordination among a broad range of investigators, patients, government agencies, and industry partners. The objective of the Cardiothoracic Surgical Trials Network (CTSN) model is to increase the effectiveness and efficiency of clinical research through shared infrastructure for important trials that will advance therapy for patients suffering from cardiac disease. (End of Abstract)

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Special Emphasis Panel (ZHL1-CSR-H (F1))
Program Officer
Miller, Marissa A
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Icahn School of Medicine at Mount Sinai
Internal Medicine/Medicine
Schools of Medicine
New York
United States
Zip Code
Capoulade, Romain; Bowdish, Michael; Kron, Irving L et al. (2017) Response by Capoulade et al to Letter Regarding Article, ""Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty"". Circulation 135:e785-e786
Ailawadi, Gorav; Chang, Helena L; O'Gara, Patrick T et al. (2017) Pneumonia after cardiac surgery: Experience of the National Institutes of Health/Canadian Institutes of Health Research Cardiothoracic Surgical Trials Network. J Thorac Cardiovasc Surg 153:1384-1391.e3
Bouchard, Denis; Perrault, Louis P; Kron, Irving L et al. (2017) Predicting recurrent mitral regurgitation after mitral valve repair: A difficult endeavor and a necessity. J Thorac Cardiovasc Surg 153:145-146
Mack, Michael J; Acker, Michael A; Gelijns, Annetine C et al. (2017) Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA 318:536-547
Capoulade, Romain; Zeng, Xin; Overbey, Jessica R et al. (2016) Impact of Left Ventricular to Mitral Valve Ring Mismatch on Recurrent Ischemic Mitral Regurgitation After Ring Annuloplasty. Circulation 134:1247-1256
Greco, Giampaolo; Ferket, Bart S; D'Alessandro, David A et al. (2016) Diabetes and the Association of Postoperative Hyperglycemia With Clinical and Economic Outcomes in Cardiac Surgery. Diabetes Care 39:408-17
Goldstein, Daniel; Moskowitz, Alan J; Gelijns, Annetine C et al. (2016) Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation. N Engl J Med 374:344-53
Blossier, Jean-David; Bouchard, Denis; Michler, Robert E et al. (2016) Identifying patients who benefit from restrictive annuloplasty in ischemic mitral regurgitation: An elusive yet essential quest! Toward a patient-tailored approach. J Thorac Cardiovasc Surg 151:906-8
Englum, Brian R; Ganapathi, Asvin M; Schechter, Matthew A et al. (2016) Changes in Risk Profile and Outcomes of Patients Undergoing Surgical Aortic Valve Replacement From the Pre- to Post-Transcatheter Aortic Valve Replacement Eras. Ann Thorac Surg 101:110-7
Gillinov, A Marc; Bagiella, Emilia; Moskowitz, Alan J et al. (2016) Rate Control versus Rhythm Control for Atrial Fibrillation after Cardiac Surgery. N Engl J Med 374:1911-21

Showing the most recent 10 out of 45 publications