Southwest German Interventional Study in Acute Myocardial Infarction III

Study Overview
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Brief Summary
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SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis.

Detailed Description
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SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. All patients received reteplase, aspirin in combination with ticlopidin, and heparin. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis. In total 197 patients were included, 163 were treated by PCI. The primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.

Official Title
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Southwest German Interventional Study in Acute Myocardial Infarction III

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: early percutaneous coronary intervention
* Device: late percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of MI present for 12 h ST segment elevation of at least 1 mm in two or more limb leads, ST segment elevation of at least 2 mm in the precordial leads, or new bundlebranch block Patients eligible for thrombolysis Informed consent for participation Exclusion Criteria: Secondary or iatrogenic infarction Chronic renal insufficiency requiring dialysis Coronary anatomy unsuitable for stent placement Anticipated indication for surgical coronary revascularization within 6 months Previous MI in the area of the infarct related vessel Infarct related lesion not clearly defined

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conservative<br>no transfer for early percutaneous coronary intervention after thrombolysis | Device: late percutaneous coronary intervention<br> <br> |
| Active Comparator: early PCI<br>transfer for early percutaneous coronary intervention after thrombolysis | Device: early percutaneous coronary intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Total mortality as well as cardiac and noncardiac deaths were counted. | 6 months | 
| Reinfarction | Reinfarction was defined as two or more of the following criteria: chest pain lasting for more than 30 minutes; a new significant ST-elevation; and a rise in the serum creatine kinase level to more than >3x upper normal limit. | 6 months | 
| Ischemic Events | Ischemic events included unplanned hospitalization and / or unplanned angiography due to postinfarction angina, recurrent angina pectoris lasting for more than 15 minutes despite the administration of nitrates, or being accompanied by electrocardiogram changes, pulmonary edema, or hypotension. | 6 months | 
| Target Vessel Revascularization | Target vessel revascularization was defined as any repeated percutaneous coronary intervention or coronary artery bypass graft surgery involving the infarct related lesion. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myocardial infarction, thrombolysis, percutaneous coronary interention