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

Solicitation Number: NHLBI-HC-09-08
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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NHLBI-HC-09-08
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Solicitation
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Added: Apr 29, 2008 1:08 pm
The National Heart Lung and Blood Institute seeks an Echocardiography Reading Center (Echo RC) for the Coronary Artery Disease Risk Development in Young Adult (CARDIA) Study renewal project. The CARDIA renewal involves a Year 25 clinical examination (Year 25 Exam) of the cohort that includes repeat and new measures to be performed June 2010 through May 2011; and continued follow-up contact and clinical events surveillance of the cohort through September 30, 2013. All surviving and willing members of the CARDIA cohort will be followed up by the Field Centers and included in the Year 25 Exam; it is estimated that approximately 3600 participants will be examined. The CARDIA Echo RCís effort is expected to begin on March 1, 2009 and to end September 30, 2013. The Echo RC contractor will be responsible for the various aspects related to the echocardiographic measurements to be collected and assessed in the Year 25 Exam.



The CARDIA Study started as a study of the distribution and evolution of risk factors for cardiovascular disease during young adulthood in black and white men and women. The Study began recruitment in 1985 in a cohort of 5,115 men and women aged 18-30 years in four communities. The original cohort had approximately equal representation by blacks and whites, men and women, those aged 18-24 and 25-30 years, and those with no more than and more than a high school education. The baseline examination (Year 0) was conducted over a 14-month period during 1985-86. The examination consisted of questionnaires on sociodemographic characteristics, health behaviors, and psychological factors; an exercise treadmill test; resting electrocardiography; a diet history assessment; anthropometry; pulmonary function testing; and resting blood pressure. Fasting blood measurements included total cholesterol and its subfractions, insulin, glucose, liver enzymes and other serum chemistry measurements, and hematology.



Six additional examinations have been completed every 2-5 years, including a Year 20 examination completed in 2006. Repeat measurements on traditional risk factors, including plasma lipids, blood pressure, anthropometry, smoking behavior, physical activity, and pulmonary function testing (except Years 7 and 15) have used the same methods at each examination to assess age and secular trends in these factors during young adulthood. In selected years, additional measurements have been made, including a treadmill exercise test at baseline and Year 7; diet history at baseline, Year 7, and Year 20; cardiovascular reactivity measurements in Year 2; echocardiography at Year 5 and in a subset at Year 10; ambulatory blood pressure monitoring (in a subset) at Year 5; skin reflectance and assessment of the experience of discrimination and other psychosocial measures and urine sodium and creatinine in Year 7; glucose tolerance testing and microalbuminuria in Year 10 and Year 20; coronary CT scan in Year 15 and Year 20; and carotid intima media thickness in Year 20.



Retention of the surviving cohort was 90, 86, 81, 79, 74, and 72 percent at each of the respective follow-up examinations. Cohort members are contacted every six months to obtain information on vital status and current residence. Every other six month contact also includes speaking with the participant to ascertain information on current smoking status, major illness or injury, and hospitalizations.



At the Year 25 Exam (to be conducted from June 2010 through May 2011), participants will be 43-55 years old, when risk factors and subclinical abnormalities become more prevalent and clinical events begin to emerge. CARDIA offers the opportunity to address aspects of the development and progression of subclinical vascular, ventricular, and pulmonary function abnormalities that cannot be addressed in older cohorts. The renewal of the CARDIA study will address five objectives: 1) Assess the impact of timing and varying levels of risk factors throughout young adulthood on the development of subclinical ventricular, vascular, and pulmonary function abnormalities in mid-life; 2) Examine young adult antecedents and consequences of obesity and the longitudinal relationships and interactions among adiposity, insulin resistance, and inflammation; 3) Identify determinants and trajectories of subclinical disease development in women during menopause transition compared to men of similar age; 4) Further assess the basis for racial differences in subclinical disease development; 5) Provide a platform for in-depth ancillary studies in cardiovascular and other areas.



The technical requirements associated with this acquisition for the CARDIA Echo RC include the following:

1. Participate in the CARDIA Steering Committee, the Imaging Committee and Quality Control Committee, as appropriate.

2. Develop the protocol for the acquisition and reading/information abstraction of the echocardiograms to be performed as part of the CARDIA Year 25 Exam.

3. Determine comparability of the proposed CARDIA Year 25 echocardiographic measurement to that from the Year 5 Exam by performing repeat measures of about 200 videotaped Year 5 echocardiographic studies plus 10% blind duplicates of the Year 5 echocardiographic studies.

4. Propose a plan to assess 20-year changes in echocardiographic measurements, particularly left ventricular structure and function, in the CARDIA cohort.

5. Convert the videotaped echocardiograms obtained from the CARDIA Y5 and Y10 Exams into digital electronic files and copy onto DVDs for secure archival storage.

6. Train and certify Field Centersí echocardiography technicians according to protocol.

7. 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

8. Conduct a pretest of the Year 25 echocardiography protocol, including quality assurance activities, during the pilot testing phase of the Year 25 Exam, in collaboration with the CARDIA Coordinating and Field Centers.

9. Perform readings/information abstractions of echocardiograms in a timely manner during the pilot phase and throughout the Year 25 Exam period.

10. In collaboration with the Steering Committee, provide advice on the development of clinical alert values for reporting results to participants.

11. In collaboration with the Coordinating Center and Field Centers, provide timely reporting of clinically significant results to participants.

12. Track the receipt, reading, and storage of echocardiograms

13. Develop and implement long-term archiving and storage of echocardiograms and timely creation of backup copies.

14. Visit CARDIA Field Centers during the early phase of the Year 25 Exam and as needed, in support of quality assurance efforts of the study.

15. Participate actively in data analysis, presentation, and publication using the echocardiographic data.

16. Prepare and submit technical and financial reports as specified herein.



The North American Industry Classification System (NAICS) Code is 541712, Size Standard - 500 employees. It is anticipated that one cost reimbursement contract will be made for a period of four years and seven months beginning on or about March 2009. There is no incumbent. RFP NHLBI-HC-09-08 will be available electronically on or about May 14, 2008 and may be accessed through the Internet at the Federal Business Opportunities (FedBizOps) website: https://www.fbo.gov/index?cck=1&au=&ck ; or the National Heart Lung and Blood Instituteís Grants and Contracts Funding Opportunity Announcement website: http://www.nhlbi.nih.gov/funding/inits/index.htm



Proposals will be due on or about July 8, 2008. Offerors are responsible for downloading their own copy of the solicitation and for routinely checking the Internet site for any solicitation amendments that may be issued by the Government. This advertisement does not commit the Government to award a contract.



Original Point of Contact

Cheryl Jennings, Contracting Officer, Phone (301)435-0347, Fax (301)480-3430, E-mail cj19f@nih.gov

Jeffrey, Contract Specialist, Phone (301)435-0338, Fax (301)435-0338,

E-mail williamsja2@nhlbi.nih.gov



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Solicitation 1

Type:
Solicitation
Posted Date:
May 15, 2008
Description: RFP NHLBI-HC-09-08
Description: Attachment 1- Packaging and Delivery of Proposal (R&D)
Description: Attachment 2- Proposal Intent Response Sheet
Description: Attachment 3- Statement of Work

Amendment 1

Type:
Mod/Amendment
Posted Date:
June 19, 2008
Amendment 1.pdf (111.55 Kb)
Description: RFP NHLBI-HC-09-08 Amendment 1
:
Office of Acquisitions
6701 Rockledge Dr RKL2/6100 MSC 7902
Bethesda, Maryland 20892-7902
:
Cheryl P Jennings,
Contracting Officer
Phone: (301) 435-0347
Fax: (301) 480-3430
:
Jeffrey A Williams,
Contract Specialist
Phone: (301) 435-0338
Fax: (301) 480-3338