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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT01124890
First received: May 11, 2010
Last updated: May 14, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Device: percutaneous coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Southwest German Interventional Study in Acute Myocardial Infarction III

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

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


Secondary Outcome Measures:
  • Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Total mortality as well as cardiac and noncardiac deaths were counted.

  • Reinfarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Target vessel revascularization was defined as any repeated percutaneous coronary intervention or coronary artery bypass graft surgery involving the infarct related lesion.


Enrollment: 197
Study Start Date: July 1998
Study Completion Date: October 2009
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124890

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Scheller, MD, University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT01124890     History of Changes
Other Study ID Numbers: BS S3
Study First Received: May 11, 2010
Last Updated: May 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
acute myocardial infarction
thrombolysis
percutaneous coronary interention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014