Southwest German Interventional Study in Acute Myocardial Infarction III

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Device: early percutaneous coronary intervention; Device: late percutaneous coronary intervention

• Registration Number: NCT01124890
• Lead Sponsor: University Hospital, Saarland

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. 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

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.

Study Timeline

• Study Start: 1998-07
• Primary Completion: 2001-10
• Study Completion: 2009-10
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early PCI	early percutaneous coronary intervention	transfer for early percutaneous coronary intervention after thrombolysis
Conservative	late percutaneous coronary intervention	no transfer for early percutaneous coronary intervention after thrombolysis

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital, Klinik fuer Innere Medizin III; 🇩🇪 Homburg/Saar, Germany