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Completed

NCT Number: NCT01124890

Southwest German Interventional Study in Acute Myocardial Infarction III

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital, Klinik fuer Innere Medizin III

Homburg/Saar, 66421, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early percutaneous coronary intervention

Device

late percutaneous coronary intervention

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Saarland

Other

Registry information

Acronym: SIAMIII

Important dates

Study start
1998
Primary completion
2001
Study completion
2009
First posted
May 17, 2010
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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