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Clinical Trials/NCT00954668
NCT00954668
Withdrawn
Not Applicable

ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)

University of Leipzig1 site in 1 countryJanuary 1, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-ST-elevation Myocardial Infarction
Sponsor
University of Leipzig
Locations
1
Primary Endpoint
Death and non-fatal recurrent infarction
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.

Registry
clinicaltrials.gov
Start Date
January 1, 2009
End Date
January 1, 2009
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Leipzig
Responsible Party
Principal Investigator
Principal Investigator

Holger Thiele

Clinical Professor Prof. Dr. Holger Thiele

University of Leipzig

Eligibility Criteria

Inclusion Criteria

  • NSTEMI with
  • ischemic symptoms \>10 minutes within 24 h
  • elevated troponin or creatine kinase above the upper limit of normal
  • ST-segment depression or transient ST-segment elevation, T-wave inversion
  • informed consent.

Exclusion Criteria

  • Age \< 18 years
  • Age \> 90 years
  • persistent angina
  • hemodynamic instability
  • overt congestive heart failure
  • life-threatening arrhythmias
  • limited life-expectancy \< 6 months
  • chronic oral anticoagulation
  • fibrinolysis \< 48 hours
  • PCI \< 14 days

Outcomes

Primary Outcomes

Death and non-fatal recurrent infarction

Time Frame: 6 months

Secondary Outcomes

  • Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization(6 months)

Study Sites (1)

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