SIAM III: Southwest German Interventional Study in Acute Myocardial Infarction III
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Conservative no transfer for early percutaneous coronary intervention after thrombolysis |
Device: percutaneous coronary intervention
|
| Active Comparator: early PCI transfer for early percutaneous coronary intervention after thrombolysis |
Device: percutaneous coronary intervention
|
Outcome Measures
Primary Outcome Measures
- Major Adverse Cardiovascular Events [6 months]
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
Secondary Outcome Measures
- Death [6 months]
Total mortality as well as cardiac and noncardiac deaths were counted.
- Reinfarction [6 months]
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.
- Ischemic Events [6 months]
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.
- Target Vessel Revascularization [6 months]
Target vessel revascularization was defined as any repeated percutaneous coronary intervention or coronary artery bypass graft surgery involving the infarct related lesion.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital, Klinik fuer Innere Medizin III | Homburg/Saar | Germany | 66421 |
Sponsors and Collaborators
- University Hospital, Saarland
Investigators
- Principal Investigator: Bruno Scheller, MD, University of Saarland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BS S3