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Southwest German Interventional Study in Acute Myocardial Infarction III (SIAM III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01124890
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : May 17, 2010
Information provided by:
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. 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: percutaneous coronary intervention Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Southwest German Interventional Study in Acute Myocardial Infarction III
Study Start Date : July 1998
Actual Primary Completion Date : October 2001
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Conservative
no transfer for early percutaneous coronary intervention after thrombolysis
Device: percutaneous coronary intervention
Active Comparator: early PCI
transfer for early percutaneous coronary intervention after thrombolysis
Device: percutaneous coronary intervention

Primary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ Time Frame: 6 months ]
    The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.

Secondary Outcome Measures :
  1. Death [ Time Frame: 6 months ]
    Total mortality as well as cardiac and noncardiac deaths were counted.

  2. Reinfarction [ Time Frame: 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.

  3. Ischemic Events [ Time Frame: 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.

  4. Target Vessel Revascularization [ Time Frame: 6 months ]
    Target vessel revascularization was defined as any repeated percutaneous coronary intervention or coronary artery bypass graft surgery involving the infarct related lesion.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01124890

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University Hospital, Klinik fuer Innere Medizin III
Homburg/Saar, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
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Principal Investigator: Bruno Scheller, MD University of Saarland

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bruno Scheller, MD, University Hospital, Saarland Identifier: NCT01124890    
Other Study ID Numbers: BS S3
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: May 17, 2010
Last Verified: May 2010
Keywords provided by University Hospital, Saarland:
acute myocardial infarction
percutaneous coronary interention
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases