Announcement for Solicitation of Satellite Sites
Background
The Cardiothoracic Surgical Trials Network (CTSN) was established in 2007 with support from the National Heart, Lung, and Blood Institute (NHLBI), the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH), and the Canadian Institutes of Health Research (CIHR).
The goal of the Cardiothoracic Surgery Network (CTSN) is to establish a cooperative network of cardiac surgery programs to promulgate the use of evidence-based medicine in surgical practice. The Network is intended to design, conduct, and analyze important, randomized clinical trials and observational studies, disseminate the results, and thereby translate the findings into clinical practice.
The Network currently consists of 8 Core Clinical Sites in the USA and Canada. 5 Affiliate Sites, who have a direct relationship and/or shared resources with a Core site and 5 Ancillary Sites, who have a contractual relationship with a Core site, also participate in the Network. The CTSN Data Coordinating Center (DCC) is located at the International Center for Health Outcomes and Innovation Research (InCHOIR), The Mount Sinai School of Medicine, N.Y.
Solicitation Announcement
The Network is soliciting Satellite Sites (investigative sites outside the CTSN) to participate in Network trials, specifically the Moderate and Severe Ischemic Mitral regurgitation trials, to enhance recruitment, provide additional clinical expertise, and participate in the intellectual output of the Network. The information required in response to this solicitation has been determined to be essential in the evaluation, review and sub-award contract process. The application document will demonstrate the Satellite Site’s ability to participate in the clinical trials of the Network and adhere to the processes described in the research protocols and manual of operations.
Applicant Requisites
The potential Satellite Site must have a large volume of cardiothoracic surgery with a substantial number of patients that meet enrollment criteria for the two trials described below. In addition, the sites must have a favorable history of collaboration in clinical research and successful enrollment in surgical trials, institutional support and established relationships between the Surgical program and interventional, echocardiology and general cardiology. For the purpose of the MR trials, all surgeries are performed on bypass and participating cardiothoracic surgeons must be willing to perform:
For Severe Ischemic MR Trial (SMR)
- Mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering or
- Mitral valve replacement and complete preservation of the sub-valvular apparatus
For Moderate Ischemic MR Trial (MMR)
- Coronary Artery Bypass Grafting (CABG) + Mitral Valve Repair or
- CABG Alone
Application Process
Each potential Satellite Site will need to complete an application document. In this application document, the applicant will need to document:
- the Site's clinical trials experience and clinical and research infrastructure,
- the Site's track record in recruiting patients for surgical clinical trials and
- the Site's enrollment potential for the current Network trials (MMR and SMR) and
- Standard NIH Biosketches or CVs, license and human subject training certification for the PI, Co-I, Sub-investigators and all other key personnel assigned to work on this project.
Selection Process
The potential Satellite Site will submit their application document (and supporting materials) to the CTSN Data Coordinating Center (DCC) for review of completeness. The DCC will distribute the materials to the CTSN Satellite Site Sub-Committee for evaluation and recommendation. Complete application documents will be reviewed for responsiveness to the requirements specified and willingness to participate in CTSN trials within the budget approved by NHLBI. Final approval of a satellite site application will occur upon majority vote from the CTSN Steering Committee. Satellite sites will be notified of final decisions by the DCC.
All materials must be received at the DCC by March 15, 2010. Satellite sites will be notified by April 1, 2010 of the decision of the CTSN Steering Committee.
Satellite Site Guidelines
Satellite Site Application
MMR Protocol Summary
SMR Protocol Summary
Integrated Echo acquisition protocol