National Heart, Lung, and Blood Institute, NIH, Contracts Operations Branch, II Rockledge Building, MSC 7902, 6701 Rockledge Drive, Bethesda, MD 20892-7902

A -- SUBCLINICAL CARDIOVASCULAR DISEASE STUDY, SPECIAL LABORATORY CENTER SOL NHLBI HC-98-09 DUE 011498 POC Cheryl A. Jennings, Contracting Officer, Internet Address cj19f@nih.gov, telephone 301-435-0345, facsimile 301-480-3430 The National Heart, Lung, and Blood Institute (NHLBI) is soliciting proposals from organizations/institutions to conduct an epidemiology study of subclinical cardiovascular disease. This Request for Proposals (RFP) NHLBI-HC-98-09 is for the Subclinical Cardiovascular Disease Study, Special Laboratory Center. The Subclinical Cardiovascular Disease Study is a study of the characteristics of subclinical cardiovascular disease (disease detected non-invasively before it has produced signs and symptoms) tha t predict progression to clinically overt cardiovascular disease in a diverse and representative population-based sample of men and women aged 35-84. Eighteen thousand men and women aged 35 to 84 will be recruited for an initial examination in this prospective study. The broad age range will permit analysis of important interactions between age and risk factor-subclinical disease relationships and between age and subclinical disease-event relationships. The large total number is necessary to ensure the a ccrual of a sufficient number of coronary heart disease events over a five- to six-year morbidity and mortality follow-up period. Initial recruitment will be population-based with the goal of enrolling approximately 50% minority participants, including roughly equal numbers of non-Hispanic blacks, Hispanics, and Pacific Islanders/Asians. The study will involve six to eight Field Centers, a Coordinating Center (which will subcontract for a Central Lipid Laboratory), a Special Laboratory Center; and separate Reading Centers for Ultrasonography, Magnetic Resonance Imaging, and Electron Beam Computed Tomography (EBCT). To allow for the expected continued rapid evolution of subclinical disease measures in the next few years, the choice of the most appropriate screening measure will be made during final protocol development in collaboration with study investigators. The timeline for this study will begin with an initial 18-month protocol planning, OMB clearance, pilot testing and training period. This will be followed by a two-year screening examination for all participants to identify the highest risk groups in age-race/ethnicity-gender-specific strata. A subsample of participants at the highest end of the subclinical disease distribution and a random sample will undergo a comprehensive examination within 6 months of screening. The comprehens ive examination will include more detailed measures of large and small vessel disease as described below. The numbers of participants in these subsamples will be determined during protocol development, based on the estimated power to conduct analyses of risk factors for subclinical disease progression and development of clinical events and for comparing the high risk subsample and random sample to identify relationships between risk factors and subclinical disease. For purposes of power and sample size es timation, each subgroup was assumed to be 10% of the total cohort, with oversampling of the high-risk group to compensate for medical and surgical intervention. The remaining participants (those not in either subsample) will not be periodically re-examined as is typically done in traditional epidemiologic studies; rather, they will be contacted annually for ascertainment of morbidity and mortality only. For the high risk and random sample subgroups, follow-up examinations at periodic intervals (e.g., 6-12 months) will focus on biochemical and other factors more proximally associated with events. Smaller subsets of particular interest may be selected to undergo more frequent follow-up or specialized examinations particularly for subclinical disease. The timing and composition of repeat subclinical disease measures will depend on the temporal nature of the measurement in its relation to clinical outcomes, demonstrated reliability of the measurement techniques in this population, the relationships found among measures, and the specific measures found most likely to progress to clinically overt events. The subsamples will also be followed for morbidity and mortality for a five- to six-year period, to allow accrual of a sufficient number of fatal and nonfatal events for completion of study objectives. The original cohort of 18,000 will also be followed for events, to allow relationships between screening variables and events to be analyzed. Completion of morbidity and mortality follow-up for the study will be followed by a period of final data analysis and study close-out, bringing the contract period to a total of 10 years. There will be one award. The period of performance is anticipated for ten years in September 1998. The Request for Proposal (RFP) NHLBI-HC-98-09 will be available on or about November 3, 1997, with proposals due January 14, 1998. Offerors other than United States of America institutions will not be considered based on the need for scientifically comparable data. This solicitation and instructions may be accessed upon release through the NIH Home Page or the NIH Gopher by using the following electronic m ail addresses and instructions. To access the RFP through the NIH Gopher: Go to the URL (Universal Resource Locator) gopher://gopher.nih.gov:70/11/res/rd-rfp. Select RFP's Available, then NHLBI. A list of RFP's will appear. Select RFP No. NHLBI-HC-98-09. To access the RFP through the World Wide Web (WWW): Go to the NIH Home Page at URL http://www.nih.gov. At the NIH Home Page, select Grants and Contracts, then select the Contracts Page. Next select the NIH Gopher Directory. The URL for the NIH Goph er Directory is gopher://gopher.nih.gov:70/11/res. From the Gopher menu, select R&D Request for Proposals, then select RFPs Available, then select NHLBI. Select RFP NHLBI-HC-98-09. Follow the directions for a Streamlined Technical RFP. All information required to submit an offer is in the electronic RFP package. Point of contact: Cheryl A. Jennings, Contracting Officer, Internet electronic mail address cj19f@nih.gov, telephone 301-435-0345, facsimile 301-480-3430. No collect calls will be accepted. Y our request should cite "RFP NHLBI-HC-98-09." (0290)

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