SOLICITATION NOTICE
A -- Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
- Notice Date
- 4/7/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Division of Research Acquisition, 6100 Executive Boulevard, Room 6E01, MSC 7540, Bethesda, MD, 20892-7540
- ZIP Code
- 20892-7540
- Solicitation Number
- AG-260-05-10
- Response Due
- 6/6/2005
- Description
- The National Institute on Aging (NIA), National Institutes of Health (NIH), has a requirement to perform a randomized, double-blinded, placebo-controlled prospective phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size and left ventricle (LV) remodeling in patients with ST-elevation myocardial infarctions. The Contractor shall be required to recruit and obtain a signed consent form, within a time period of approximately 15 months, from approximately 150 men and women with acute ST-elevation myocardial infarctions who are referred to the cardiac catheterization laboratory for primary or rescue percutaneous coronary intervention. The Contractor shall be required to perform, on all recruited subjects, contrast enhanced cardiac magnetic resonance imaging (MRI) as early as possible after enrollment, but no later than 48-72 hours from the time of randomization. The Contractor shall be required to repeat the contrast enhanced cardiac magnetic resonance imaging study on subjects approximately four to six months later. For each MRI, the Contractor shall measure cardiac volumes, ejection fraction, left ventricular mass, and infarct size, and assess myocardial perfusion, to assess for changes in these variables and for the extent of infarct expansion. The Contractor shall also collect blood, measuring a number of levels, including the number of circulating endothelial progenitor cells in fresh blood samples (i.e. collected within approximately 4 hours of the test) at the time of enrollment into the study when feasible, and approximately 24-48 hours after administration of the study medication. The Contractor shall perform safety monitoring, including establishing a data and safety monitoring board. Finally, the Contractor shall be required to perform detailed statistical analyses of all the test results. It is estimated that a two (2) year, cost-reimbursement completion type contract will be awarded. The following are mandatory qualification criteria that must be met at the time proposals are submitted: The Offeror must have a cardiac catheterization laboratory that performs primary and rescue percutaneous coronary interventions; the Offeror must possess the necessary equipment and software to perform contrast enhanced cardiac magnetic resonance imaging; and, the Offeror must have access to a laboratory skilled in measuring circulating endothelial progenitor cells. Other non-mandatory criteria include the Offeror having expertise and experience in successfully conducting similar research projects, including studies involving pharmacologic interventions, in working with patients with acute ST-elevation myocardial infarctions, and in recruiting and retaining participants for clinical research studies; and, the Offeror having experience performing contrast enhanced cardiac magnetic resonance imaging, as well as measuring the number of circulating endothelial progenitor cells in fresh blood samples. THE SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. It will be available on this website on or about 15 calendar days from the date of the publication of this synopsis. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal which shall be considered. No collect calls will be accepted.
- Record
- SN00784190-W 20050409/050407211909 (fbodaily.com)
- Source
-
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