CLINICAL CENTERS FOR THE ANGIOGRAPHIC TRIAL IN WOMEN NIH GUIDE, Volume 21, Number 43, November 27, 1992 RFP AVAILABLE: NHLBI-HV-92-43 P.T. 34, II Keywords: Clinical Trial Cardiovascular Diseases Medical/Diagnostic Imaging Hormones 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) Cholesterol-lowering diet and antioxidants; and (3) Drugs that lower LDL-cholesterol versus drugs that, in addition, raise HDL-cholesterol levels. Angiographic changes will be primary endpoints of all three trials. Quantitative computerized analysis of the angiograms will be performed by a central angiographic facility. In addition, it is proposed to follow lipid and clotting parameters, which will be analyzed by a central laboratory facility. The study population for the first and third trials will consist of 208 women, and the second, 152 women, with angiographically documented CAD defined as at least 30 percent but no more than 75 percent occlusion of any single coronary artery. The following will be exclusion criteria: (1) age over 75; (2) any condition that would compromise participation in the study or the likelihood of obtaining exit angiograms, such as a life-threatening disease or a chronic illness likely to require frequent hospitalizations and/or treatment adjustments that may affect outcome variables; (3) contraindications to the use of any of the study interventions; and (4) clear need for treatment with any of the interventions for this trial. It is estimated that 50 percent of eligible women requiring angiographic evaluation will agree to participate in the study, and 50 percent of these women will meet the angiographic criteria. Three to six awards are anticipated. These incrementally funded contracts will be awarded for five years. This announcement is not a request for proposals (RFP). RFP NHLBI-HV-92-43 will be released on or about November 25, 1992 with proposals due on or about February 1, 1993. Written request must include three self-addressed mailing labels and must cite RFP No. NHLBI-HV-92-43. 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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