Coronary Artery Risk Development in Young Adults (CARDIA) Study - Birmingham, AL Field Center

The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) plans to establish a field center in the Birmingham, AL area as part of the Coronary Artery Risk Development in Young Adults (CARDIA) Study renewal. The CARDIA study involves a limited examination (Year 30) of the cohort in June 01, 2015 thru May 31, 2016; as well as continued follow-up contact and clinical events surveillance of the cohort. The Field Center's effort is expected to begin on July 01, 2013 and to end on June 30, 2018.

CARDIA began in 1985 in four U.S. communities (Birmingham, AL; Chicago, IL; Minneapolis, MN; and Oakland, CA). The original cohort (n=5,115) was selected to have approximately the same number of participants in subgroups of age (18-24 and 25-30), sex, race (black and white), and education (high school or less and more than high school) within each community. Seven additional examinations have been completed every 2-5 years, including a Year 25 examination completed in 2011.

The objectives of the renewal of the CARDIA program are: (1) to perform a limited examination of the cohort to determine abnormalities in cardiac structure and function that exist in a community-based sample of mid-to-late middle-aged adults; to utilize novel measures to better understand myocardial dysfunction; to examine 25-year trajectories in cardiac structure and function; and to assess whether these abnormalities and trajectories differ between white and black adults; (2) to continue cohort follow-up for cardiovascular events, including heart failure, coronary heart disease, stroke, and atrial fibrillation; and (3) to provide a platform for ancillary studies particularly to the cohort examination, a training ground for new investigators, and support data sharing. These objectives will be accomplished through annual follow-up and a ninth (Year 30) examination of the existing cohort.

The CARDIA Field Center contractors shall be responsible for the tasks, including but not limited to the following:

• Ensure that the protocol specifies comparability of repeat measures with those previously collected where trend analysis is planned.
• Collaboration with other Field Centers and the Coordinating Center in the development of an informed consent template with common language for all Field Centers.
• Recruit, obtain signed informed consent, and conduct the Year 30 examination for all available cohort survivors.
• Provide for handling of collected blood and urine specimens including shipping to the Central Laboratory and long-term storage for future measurements of additional biomarkers.
• Provide participants with referrals for follow-up of medically relevant abnormal findings within a local network of health care providers or institutions to which participants can be referred if indicated.
• Contact all surviving CARDIA cohort members annually and develop a local plan to maintain an annual cohort retention rate as high as possible, but over 80% at a minimum.
• Design and execute a plan to continue community relations to enhance communication of study progress and findings to study participants.
• Use the system recommended or provided and maintained by the Coordinating Center for participant data entry and transfer from Field Centers to the Coordinating Center or Reading Centers.
• Provide a plan for transition of responsibilities, data, and materials from the existing Field Center to the new Offeror.
• Formulate hypotheses/research questions, and propose and write manuscripts and ancillary studies to achieve the scientific goals of the study.

NHLBI plans to support 1 Coordinating Center, 4 Field Centers and 1 Echocardiography Reading Center. THIS NOTICE ADDRESSES THE BIRMINGHAM, ALABAMA FIELD CENTER ONLY.

Potential offerors are responsible for accessing this web site and downloading the RFP and any attachments. It is also the offerors' responsibility to monitor the FedBizOpps web page for the release of any amendments to the RFP. Interested parties must respond to the solicitation in order to be considered for award of any resultant contract. Letters of intent are due no later than July 27, 2012. This acquisition has been designated as a full and open competition under the North American Industry Classification System (NAICS) code 541712. Subcontracting opportunities are anticipated during the course of this contract award. Potential offerors are required to direct all questions via e-mail to zollere@nhlbi.nih.gov.

NOTE: PREPARATION COSTS - This solicitation notice does not commit the Government to pay for preparation and submission of any materials.