Southwest German Interventional Study in Acute Myocardial Infarction III

Acute Myocardial Infarction Clinical Trial

— SIAMIII  

Official title:

Southwest German Interventional Study in Acute Myocardial Infarction III

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124890
• Other study ID #: BS S3
• Status: Completed
• Phase: Phase 4
• Start date: July 1998
• Est. completion date: October 2009

Study information

• Verified date: April 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 2009
• Est. primary completion date: October 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• early percutaneous coronary intervention

• late percutaneous coronary intervention

Locations

Country	Name	City	State
Germany	University Hospital, Klinik fuer Innere Medizin III	Homburg/Saar

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Scheller B, Hennen B, Hammer B, Walle J, Hofer C, Hilpert V, Winter H, Nickenig G, Bohm M; SIAM III Study Group. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. J Am Coll Cardiol. 2003 Aug 20;42(4):634-41. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.	6 months
Secondary	Death	Total mortality as well as cardiac and noncardiac deaths were counted.	6 months
Secondary	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
Secondary	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
Secondary	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