Confronting the issues of patient safety and investigator conflict of interest in an international clinical trial of myocardial reperfusion

The Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) trial is a large scale international trial of new myocardial reperfusion strategies. The primary hypothesis is that early and sustained coronary artery recanalization will be associated with a significant reduction in mortality. The four regimens that are being tested are 1) streptokinase with subcutaneous heparin; 2) streptokinase with intravenous heparin; 3) accelerated recombinant tissue-type plasminogen activator (rt-PA) with intravenous heparin; and 4) combination streptokinase, rt-PA and intravenous heparin. The planned recruitment of 41,600 patients in 1,500 sites from 15 countries is expected to be completed by December 1992 and will enable detection of a 15% reduction or 1% absolute difference in mortality compared with that associated with standard therapy (streptokinase and subcutaneous heparin). In designing the trial, two important issues were directly addressed. First, a strategy was developed to provide assurance of patient safety during large scale investigational use of an aggressive thrombolytic regimen. This includes fascimile transmission of a one-page safety summary form to the Data Coordinating Center within 24 h of death or discharge, acceptance of the concept of "net clinical benefit" and close surveillance of the trial's progress by the independent Data and Safety Monitoring Committee. S

Correlation of Electrocardiogram and Regional Cardiac Magnetic Resonance Imaging Findings in ST-Elevation Myocardial Infarction: A Literature Review

Background: Patients with acute ST-elevation myocardial infarction (STEMI) benefit substantially from emergent coronary reperfusion. The principal mechanism is to open the occluded coronary artery to minimize myocardial injury. Thus the size of the area at risk is a critical determinant of the patient outcome, although other factors, such as reperfusion injury, have major impact on the final infarct size. Acute coronary occlusion almost immediately induces metabolic changes within the myocardium, which can be assessed with both the electrocardiogram (ECG) and cardiac magnetic resonance (CMR) imaging. Methods: The 12-lead ECG is the principal diagnostic method to detect and risk-stratify acute STEMI. However, to achieve a correct diagnosis, it is paramount to compare different ECG parameters with golden standards in imaging, such as CMR. In this review, we discuss aspects of ECG and CMR in the assessment of acute regional ischemic changes in the myocardium using the 17 segment model of the left ventricle presented by American Heart Association (AHA), and their relation to coronary artery anatomy. Results: Using the 17 segment model of AHA, the segments 12 and 16 remain controversial. There is an important overlap in myocardial blood supply at the antero-lateral region between LAD and LCx territories concerning these two segments. Conclusion: No all-encompassing correlation can be found between ECG and CMR findings in acute ischemia with respect to coronary anatomy