CLINICAL COORDINATING CENTER FOR THE ANGIOGRAPHIC TRIAL IN WOMEN NIH GUIDE, Volume 21, Number 43, November 27, 1992 RFP AVAILABLE: NHLBI-HV-92-42 P.T. 34, II Keywords: Data Management/Analysis+ Clinical Trial Computer Storage & Retrieval Cardiovascular Diseases National Heart, Lung, and Blood Institute The primary objective of this project is to assess whether or not interventions that modify lipoproteins will inhibit progression and induce regression of coronary plaques in women; the secondary objective is to elucidate the mechanisms by which various treatments may modify atherosclerosis in women. The study will consist of three randomized angiographic trials with a common core protocol and a single Clinical Coordinating Center. Angiographic changes will be primary endpoints of all three trials. A total of 568 women with angiographically documented coronary artery disease will be enrolled to participate in one of three randomized therapeutic trials: (1) Hormone replacement therapy in postmenopausal women; (2) Cholesteral-lowering diet and antioxidants; and (3) Drugs that lower LDL-cholesterol versus drugs that, in addition, raise HDL-cholesterol levels. The program will comprise three phases. During Phase I, the Clinical Coordinating Center will participate with investigators from three to six Clinical Centers to develop detailed protocols and Manuals of Operations and to assume the responsibility for a cooperative effort with other study investigators to develop, pretest, reproduce, and distribute appropriate reporting forms. The Clinical Coordinating Center will also be responsible for establishing and working with a central laboratory facility, a central angiographic facility for quantitative coronary angiography, and a drug distribution center. The Clinical Coordinating Center will design quality control and randomization procedures. During Phase II, the Clinical Coordinating Center will be responsible for randomizing patients, monitoring recruitment, and collecting, editing, storing, and analyzing data. Throughout the course of the study, the Clinical Coordinating Center will assume the responsibility for review of the quality and timeliness of the data transmitted. The Clinical Coordinating Center will prepare reports for the Data and Safety Monitoring Board that will monitor progress of the program. During Phase III, the Clinical Coordinating Center will analyze the data and prepare and write scientific reports and manuscripts for publication and presentation, in collaboration with other study investigators and the National Heart, Lung, and Blood Institute's Program Office. One award is anticipated. This incrementally funded contract will be awarded for five years. This announcement is not a Request for Proposals (RFP). RFP NHLBI-HV-92-42 will be released on or about November 25, 1992 with proposals due on or about February 1, 1993. One award is anticipated by the Government. The written request must include three self-addressed mailing labels, and must cite RFP No. NHLBI-HV-92-42. INQUIRIES Request for copies of the RFP are to be sent to: Sharon M. Kraft, Contract Specialist HLVD Contracts Section, COB, DEA National Heart, Lung, and Blood Institute Bethesda, MD 20892 Telephone: (301) 496-6815 .
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