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Coronary Artery Risk Development in Young Adults (CARDIA) Study - Echocardiography Reading Center

Solicitation Number: NHLBI-HV-13-18
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD
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There have been modifications to this notice. To view the most recent modification/amendment, click here
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NHLBI-HV-13-18
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Award
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Added: Jul 20, 2012 2:30 pm
The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) plans to establish one (1) Echocardiography Reading Center 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 Echocardiography Reading 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 Echocardiography Reading Center contractor shall be responsible for the tasks, including but not limited to the following:


• Develop the protocol for the acquisition and reading/information abstraction of the echocardiograms to be performed as part of the CARDIA Year 30 Exam.
• Determine comparability of the proposed CARDIA Year 30 echocardiographic measurement to that from the Year 5 and Year 25 Exams by performing repeat measures of about 200 digitized Year 5 echocardiographic studies and 200 Year 25 echocardiographic studies.
• Propose a plan to evaluate myocardial function using novel techniques, particularly left ventricular function from the Year 30 echocardiographic studies. This plan should be based on sound scientific evidence and hypotheses.
• Propose a plan to assess 25-year changes (from Year 5 to Year 30) in echocardiographic measurements utilizing the Year 5 and Year 25 results, particularly left ventricular structure and function, in the CARDIA cohort.
• Train and certify Field Centers' echocardiography technicians according to protocol.
• Train and certify echocardiography readers at the Reading Center according to protocol, as well as orient professional staff from the Coordinating Center and NHLBI Project Office who have quality assurance responsibilities
• Perform readings/information abstractions of echocardiograms in a timely manner during the pilot phase and throughout the Year 30 Exam period.
• In collaboration with the Steering Committee, provide advice on the development of clinical alert values for reporting results to participants.
• In collaboration with the Coordinating Center and Field Centers, provide timely reporting of clinically significant results to participants. Reviews for clinical alerts and referrals should be performed within 14 days.
• Track the receipt, reading, and storage of echocardiograms.
• Develop and implement short-term archiving during the Year 30 Exam at the Field Centers, long-term archiving and storage of echocardiograms, and timely creation of backup copies.
• Participate actively in data analysis, presentation, and publication using the echocardiographic data.


NHLBI plans to support 1 Coordinating Center, 4 Field Centers and 1 Echocardiography Reading Center. THIS NOTICE ADDRESSES THE ECHOCARDIOGRAPHY READING 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 Amrana.Ali@nih.gov.


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

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Request for Proposals

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
Request for Proposals
Posted Date:
July 20, 2012
Description: NHLBI-HV-13-18 RFP

Amendment 1

Type:
Mod/Amendment
Posted Date:
August 7, 2012
Description: Amendment 1

Amendment 2

Type:
Mod/Amendment
Posted Date:
August 20, 2012
Description: NHLBI-HV-13-18 Amendment #2
Description: Revised CARDIA Echo Reading Center Statement of Work

Amendment 3

Type:
Mod/Amendment
Posted Date:
September 19, 2012
Description: Amendment 3: To revise Section L Instructions to Offerors
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Office of Acquisitions
6701 Rockledge Dr RKL2/6100 MSC 7902
Bethesda, Maryland 20892-7902
:
Elizabeth Zoller
Phone: 301-435-0374
Fax: 301-480-3430
:
Cheryl A Jennings,
Contracting Officer
Phone: (301) 435-0347
Fax: (301) 480-3430