Southwest German Interventional Study in Acute Myocardial Infarction III
SIAMIII
1 other identifier
interventional
197
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 1998
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 11, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedApril 27, 2023
April 1, 2023
3.3 years
May 11, 2010
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiovascular Events
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
6 months
Secondary Outcomes (4)
Death
6 months
Reinfarction
6 months
Ischemic Events
6 months
Target Vessel Revascularization
6 months
Study Arms (2)
Conservative
PLACEBO COMPARATORno transfer for early percutaneous coronary intervention after thrombolysis
early PCI
ACTIVE COMPARATORtransfer for early percutaneous coronary intervention after thrombolysis
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Klinik fuer Innere Medizin III
Homburg/Saar, 66421, Germany
Related Publications (2)
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.
PMID: 12932593RESULTClever 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.
PMID: 21712524DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno Scheller, MD
University of Saarland
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2010
First Posted
May 17, 2010
Study Start
July 1, 1998
Primary Completion
October 1, 2001
Study Completion
October 1, 2009
Last Updated
April 27, 2023
Record last verified: 2023-04