Clinical trial NCT01124890: Southwest German Interventional Study in Acute Myocardial Infarction III
Official title: Southwest German Interventional Study in Acute Myocardial Infarction III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
thrombolysis
percutaneous coronary interention
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2010-05-17
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 6 months
Secondary outcomes:
measure: Death
timeFrame: 6 months
measure: Reinfarction
timeFrame: 6 months
measure: Ischemic Events
timeFrame: 6 months
measure: Target Vessel Revascularization
timeFrame: 6 months
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: University Hospital, Klinik fuer Innere Medizin III
Study officials:
affiliation: University of Saarland
name: Bruno Scheller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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: 10.1016/s0735-1097(03)00763-0.
citation: Clever YP, Cremers B, Link A, Bohm M, Scheller B. Long-term follow-up of early versus delayed invasive approach after fibrinolysis in acute myocardial infarction. Circ Cardiovasc Interv. 2011 Aug;4(4):342-8. doi: 10.1161/CIRCINTERVENTIONS.111.962316. Epub 2011 Jun 28.