NIH, National Heart, Lung, & Blood Institute, DECA Contracts Section, Contracts Operations Branch, Rockledge Building (RKL2), Room 6132 6701 ROCKLEDGE DR MSC 7902, BETHESDA MD 20892-7902

A -- MAGNESIUM IN CORONARIES SOL NOT APPLICABLE POC Lisa O'Neill, Contracting Officer (301) 435-0353. The National Heart, Lung, and Blood Institute is conducting a market survey to determine the availability and potential capability of small business firms (SIC Code 8731-500 employees) to perform as a Clinical Trial Center (CTC). The purpose of this study is to determine whether patients with suspected acute MI and who are at high risk for mortality can benefit from early administration of intravenous magnesium. Patients with acute myocardial infarction who do not receive thrombolytic therapy or primary angioplasty will be randomized 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 with approximately 300 clinic sites participating in this trial. Necessary functions of the coordinating center will include: participation in the development of the study protocol and data collection forms; development of procedures for random allocation of patients to treatment groups; design and implementation of procedures to evaluate clinical investigators; provide on-going quality control and management procedures; train clinical staff; monitor adverse effects; prepare technical and statistical reports for a Data and Safety Monitoring Board; develop procedures for reimbursement of clinical investigators for accepted data forms; and develop appropriate methods of analysis and presentation of data collected during the course of the study. Information provided should establish: 1) professional qualifications of medical and scientific staff with expertise in clinical cardiology, management of myocardial infarction, congestive heart failure, data collection, data monitoring, quality control, management of side effects and adverse reactions to medical therapy; 2) the organizational flexibility to modify the labor mix to meet changing levels of demand on the resource; 3) significant experience pertnent to the development of protocols and management of multicenter clinical trials in cardiovascular disease; 4) the experience and expertise of the organization in the operation of a coordinating center for a large multicenter, randomized clinical trial in cardiovascular disease; 5) experience in analysis and interpretation of medical data for purposes of ensuring patient safety; 6) access to a large capacity computer facility and networking to remote terminals; 7) evidence of publishing scientific papers in a collaborative study; and 8) the firms status as a small business under SIC 8731, Commercial, Physical and Biological Research. This is not an RFP. No RFP is available. Three copies of the information requested above should be submitted by October 24, 1995. (0279)

Loren Data Corp. http://www.ld.com (SYN# 0005 19951010\A-0005.SOL)