Southwest German Interventional Study in Acute Myocardial Infarction III (SIAMIII)
Primary Purpose
Acute Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
early percutaneous coronary intervention
late percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction, thrombolysis, percutaneous coronary interention
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
Sites / Locations
- University Hospital, Klinik fuer Innere Medizin III
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Conservative
early PCI
Arm Description
no transfer for early percutaneous coronary intervention after thrombolysis
transfer for early percutaneous coronary intervention after thrombolysis
Outcomes
Primary Outcome Measures
Major Adverse Cardiovascular Events
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
Secondary Outcome Measures
Death
Total mortality as well as cardiac and noncardiac deaths were counted.
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.
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.
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.
Full Information
NCT ID
NCT01124890
First Posted
May 11, 2010
Last Updated
April 25, 2023
Sponsor
University Hospital, Saarland
1. Study Identification
Unique Protocol Identification Number
NCT01124890
Brief Title
Southwest German Interventional Study in Acute Myocardial Infarction III
Acronym
SIAMIII
Official Title
Southwest German Interventional Study in Acute Myocardial Infarction III
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
October 2001 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Saarland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
acute myocardial infarction, thrombolysis, percutaneous coronary interention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conservative
Arm Type
Placebo Comparator
Arm Description
no transfer for early percutaneous coronary intervention after thrombolysis
Arm Title
early PCI
Arm Type
Active Comparator
Arm Description
transfer for early percutaneous coronary intervention after thrombolysis
Intervention Type
Device
Intervention Name(s)
early percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
late percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Death
Description
Total mortality as well as cardiac and noncardiac deaths were counted.
Time Frame
6 months
Title
Reinfarction
Description
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
Title
Ischemic Events
Description
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
Title
Target Vessel Revascularization
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Scheller, MD
Organizational Affiliation
University of Saarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Klinik fuer Innere Medizin III
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
12932593
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.
Results Reference
result
PubMed Identifier
21712524
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.
Results Reference
derived
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Southwest German Interventional Study in Acute Myocardial Infarction III
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