Atherosclerosis Risk in Communities (ARIC) Study - Coordinating Center

The National Heart, Lung, and Blood Institute (NHLBI), NIH intends to negotiate on a non-competitive, sole source basis with the University of North Carolina, the Coordinating Center of the Atherosclerosis Risk in Communities (ARIC) study to award a follow-up study. The cited authority is 41 U.S.C. 252(c)(1), as set forth in FAR 6.302-1. This effort will be a six-year follow-up of the ARIC participants and continued community surveillance for cardiovascular disease. This contractor has been involved in the recruitment, follow-up, collection and analysis of data, and reporting of results on 15,792 participants selected from four communities in the United States. Additionally, this contractor has been involved in the collection and review of hospital discharge records and death certificates to monitor the trends in incidence and mortality of coronary heart disease and heart failure in the four communities. The incumbent contractor has the unique capability to provide these required services to NHLBI for the follow-up of the study. Inherent duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this study. The background and objectives of the study are detailed below. Background and Purpose of the ARIC study: ARIC is a prospective epidemiologic study conducted in four U.S. communities: Washington County, MD; Forsyth County, NC; Jackson, MS; and Minneapolis, MN. The study is designed to monitor the trends in incidence and mortality of coronary heart disease (CHD) and heart failure in communities, and to investigate the etiology and natural history of subclinical and clinical cardiovascular disease. Accordingly, ARIC includes a Community Surveillance Component and Cohort Study Component. In the community surveillance, the four communities are investigated to determine the community-wide occurrence of hospitalized myocardial infarction and CHD deaths in approximately 470,000 men and women aged 35-84 years. Starting in 2006, surveillance of inpatient (ages 55 years and older) and outpatient heart failure (ages 65 years and older) is included for the events beginning in 2005. In the cohort study, approximately 4,000 individuals aged 45-64 years were recruited by probability sampling from each of the four communities under surveillance. A total of 15,792 participants (11,478 whites, 4,266 African Americans, and 48 other) received an extensive baseline examination in 1987-1989. Three repeat examinations were conducted in 1990-92, 1993-95, and 1996-98, with a response rate of 93%, 86%, and 80%, respectively. The examinations collected information on demographics, psychosocial and behavioral factors, dietary intakes, physical measurements, and biological and genetic markers. Follow-up occurs yearly by telephone to maintain contact with participants and to assess health status of the cohort. Retention rate remains to be high (92%). There were approximately 13,000 participants alive as of December 2008. To capitalize and expand upon the resources of data, specimens, and infrastructure developed over 20 years in ARIC, this follow-up study aims to: 1) re-examine the ARIC cohort to characterize heart failure stages in the community and identify genetic and environmental factors leading to ventricular dysfunction and vascular stiffness; 2) enhance the ARIC study with cardiovascular outcomes research to assess quality and outcomes of medical care for heart failure and heart failure risk factors; 3) assess longitudinal changes in pulmonary function and identify determinants of pulmonary function decline; 4) continue cohort follow-up for outcomes measures such as CHD, atrial fibrillation, heart failure, and stroke; and for the study of factors related to progression of subclinical to clinical CVD; 5) continue community surveillance to monitor long-term trends in hospitalized MI, CHD deaths, and heart failure; and 6) provide a population laboratory platform for ancillary studies in cardiovascular and other areas. The study will serve as a valuable national resource for training young investigators. The Coordinating Center's expected responsibilities that will continue during the follow up phase include (but are not limited to) all data management and analysis activities including the documentation and maintenance of appropriate confidentiality and security of files for the study and sub-studies; lead the development of the protocol and manuals of procedures development; monitor the regulatory aspects of the study; establish standardized quality of data gathering; continue to maintain a morbidity/mortality monitoring and adjudication system; maintain quality control and monitoring of the performance status of the field centers; coordinate, arrange, participate in, and provide any information necessary for regular Steering Committee, Observations Study Monitoring Board, training and other necessary study meetings; and provide technical reports as required by the Government (up to one semiannually and a final). We anticipate subcontracting opportunities during the course of this contract. For instance, there will be a need to establish an ECG Reading Center and a Pulse Wave Velocity Reading Center. This notice of intent expires 15-days from its posting. This is not a request for proposals (RFP). The estimated award date is November 1, 2010. All responsible sources may submit written capability statements demonstrating their ability to perform this research effort on the same study participants. Any interested parties in this or potential subcontracting opportunities may contact either Kristiane Cooper, Contracting Officer, cooperke@nhlbi.nih.gov, 301-435-0345 or Elizabeth Zoller, Contract Specialist, zollere@mail.nih.gov, 301-435-0345.