A Phase 4 interventional study of early percutaneous coronary intervention and late percutaneous coronary intervention in Acute Myocardial Infarction, sponsored by University Hospital, Saarland. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by University Hospital, Saarland · Phase 4, Interventional, and Treatment
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 197 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →University Hospital, Saarland is the lead sponsor of 41 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
no transfer for early percutaneous coronary intervention after thrombolysis
Device: late percutaneous coronary intervention
transfer for early percutaneous coronary intervention after thrombolysis
Device: early percutaneous coronary intervention
Major Adverse Cardiovascular Events
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
Time frame: 6 months
Death
Total mortality as well as cardiac and noncardiac deaths were counted.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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University Hospital, Saarland