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

April 25, 2023 updated by: University Hospital, Saarland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg/Saar, Germany, 66421
        • University Hospital, Klinik fuer Innere Medizin III

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Conservative
no transfer for early percutaneous coronary intervention after thrombolysis
Device: late percutaneous coronary intervention
Active Comparator: early PCI
transfer for early percutaneous coronary intervention after thrombolysis
Device: early percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 6 months
Total mortality as well as cardiac and noncardiac deaths were counted.
6 months
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.
6 months
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (Actual)

October 1, 2001

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 14, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS S3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Myocardial Infarction

Clinical Trials on late percutaneous coronary intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe