National Institutes of Health National Heart, Lung and Blood Institute Rockledge II Building, Room 6128; 6701 Rockledge Drive, Mail Stop Code 7902 Bethesda, MD 20892-7902

A -- MAGNESIUM IN CORONARIES (MAGIC) SOL NHLBI-HC-97-10 DUE 090897 POC Peggy Mills, Contract Specialist (301/435-0351); FAX: (301/480-3430); e-mail: pm39m@nih.gov The National Heart, Lung, and Blood Institute is soliciting proposals for a Clinical Trial Center (CTC) for a large, multicenter clinical trial. The purpose of the Magnesium in Coronaries (MAGIC) Study is to determine whether patients with suspected acute myocardial infarction and who are at a high risk for mortality can benefit from early administration of intravenous magnesium. Patients undergoing reperfusion therapy (thrombolytic therapy or primary angioplasty) will be eligible provided magnesium c an be administered before or at the same time as the reperfusion therapy. Patients with acute myocardial infarction who do not receive thrombolytic therapy or primary angioplasty will be eligible if they can begin magnesium infusion within 6 hours of the onset of symptoms. The primary endpoint will be all cause mortality at 30 days following the index event. Secondary endpoints will include development of cardiogenic shock, ventricular fibrillation, congestive heart failure, and the need for a temporary pacemaker. The estimated sample size is 10,400 subjects with approximately 300 clinical sites participating in this trial. The Clinical Trial Center will have the following responsibilities: 1) a leadership role in developing the manual of operations and data collection forms; 2) provide 24-hour on call assistance by a medical doctor to the clinical sites; 3) obtain single project assurance numbers from the Department of Health and Human Services, National Institutes of Health, Office for Protection f rom Research Risks; 4) obtain clearances required by the Office of Management and Budget under the Paperwork Reduction Act; 5) develop procedures for random allocation of patients to treatment groups; 6) design and implement procedures to evaluate clinical investigators; 7) develop procedures for and provide on-going quality control and management of study data; 8) train clinical staff on procedures required by the study protocol; 9) monitor adverse patient effects; 10) prepare clinical, technical, a nd statistical reports in the form needed by a Data and Safety Monitoring Board to evaluate the safety of the protocol to patients; 11) develop procedures to reimburse clinical investigators for accepted data forms, such as participant randomizations, events, follow-up forms, and death certificates; 12) develop appropriate methods of analysis and presentation of data collected during the course of the study; and 13) prepare a training video and other training materials and distribute these items to a maxi mum of 300 Investigators. The SIC Code is 8731: Commercial, Physical and Biological Research. The anticipated period of performance is three yers, beginning on or about April 1, 1998. One completion type cost-reimbursement contract will be awarded for this randomized, placebo-controlled, double-blind study. RFP NHLBI-HC-97-10 will be available on or about July 21, 1997 with proposals due September 8, 1997. This RFP may be accessed through the NIH Home Page or the NIH Gopher by using the following elect ronic mail addresses and instructions. All amendments to the RFP will be available through the Universal Resource Locator (URL) where the original RFP No. NHLBI-HC-97-10 is located. To access the RFP through the NIH Gopher: Go to URL gopher://gopher.nih.gov:70/11/res/rd-rfp. Select RFPs Available, then NHLBI. A list of RFPs will appear. Select RFP No. NHLBI-HC-97-10. To access the RFP through the World Wide Web (WWW), go to the NIH Homepage at URL http://www.nih.gov. At the NIH Home Page, select Gra nts and Contracts, then select Contracts Page. Next select NIH Gopher Directory. The URL for the NIH Gopher Directory is gopher://gopher.nih.gov:70/11/res. From the Gopher menu, select R&D Request for Proposals, then select RFPs Available, then select NHLBI. Select RFP No. NHLBI-HC-97-10. Follow the directions for a Streamlined Technical RFP. Please note that the RFP for this procurement has been revised to include only the Work Statement, Deliverables and Reporting Requirements, Technical Evaluation Criteria, and proposal preparation instructions. All information required to submit an offer is in the electronic RFP package. This advertisement does not commit the Government to award a contract. Point of contact: Peggy Mills, Contract Specialist, electronic mail address: pm39m@nih.gov, telephone: (301)435-0351; FAX: (301) 480-3430. No collect calls will be accepted. Requests for the RFP may be in writing, addressed to Peggy Mills, or sent via the e-mail address shown above. All requests must cite "RFP NHLBI-HC-97-10." See Numbered Note #13. (0181)

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