Study Design

Study Design:

Patients Enrolled: 430

Patient Populations:

Symptoms consistent with an acute MI of <6 hours duration unresponsive to sublingual nitroglycerin; age >18 and <75 years of age; ST-segment elevation of at least 0.1 mV in at least two of six precordial leads, two of three inferior leads, or in both leads I and aVL; and ability and willingness to give informed consent to participate in this study.

Exclusions:

Treatment with Fluosol within the previous 6 months, ongoing renal dialysis, clinically significant liver disease, chronic obstructive pulmonary disease, other serious advanced illnesses likely to limit life expectancy, prolonged cardiopulmonary resuscitation (>10 minutes) within the previous 2 weeks, other standard contraindications to thrombolytic therapy, previous coronary artery bypass graft surgery, previous Q-wave infarction, and cardiogenic shock.

Primary Endpoints:

Global ejection fraction, regional wall motion analysis, infarct size as measured by tomographic thallium imaging, and a composite clinical outcome measure (death from any cause, stroke, nonfatal reinfarction, emergency revascularization, development of new heart failure or pulmonary edema, or significant recurrent ischemia).

Secondary Endpoints:

Arrhythmias, sustained hypotension, Killip class II or III, acute septal rupture, acute mitral regurgitation, pericarditis, coma, renal failure, respiratory failure, bleeding.

Drug/Procedures Used:

All patients were initially treated with 324 mg of chewable aspirin, intravenous heparin, and 100 mg of intravenous tissue-type plasminogen activator (tPA) over 3 hours. In addition, patients received intravenous atenolol unless they had atrioventricular block, systolic blood pressure <100 mm Hg, heart rate <60 beats per minute, bibasilar rales, or a significant history of bronchospasm. Intravenous morphine, nitroglycerin, and atropine also were used at the discretion of the investigator. After the initiation of the above therapy, patients were randomized to receive intravenous Fluosol (n=217) or placebo (n=213). Intravenous Fluosol was administered at the rate of 1 mL/min for the first 5 minutes, 5 mL/min for the next 5 minutes, and 20 mL/min until a total of 15 mL/kg had been administered. The rate was reduced in the presence of any sign of pulmonary congestion or edema; 77% of patients received the full dose. All patients continued to receive intravenous heparin at a rate of 1000 U/h to maintain the partial thromboplastin time at 1.5 to 2 times the control value. An effort was made to perform cardiac catheterization, including coronary angiography and left ventriculography and tomographic thallium imaging 5 to 14 days after thrombolytic therapy.