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- Withdrawn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