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

Not Applicable

Withdrawn

• Conditions: Non-ST-elevation Myocardial Infarction
• Interventions: Procedure: immediate angiography and revascularization; Procedure: early invasive angiography

• Registration Number: NCT00954668
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2009-01-01
• Study Completion: 2009-01-01
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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
• STEMI
• limited life-expectancy < 6 months
• chronic oral anticoagulation
• fibrinolysis < 48 hours
• PCI < 14 days
• contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel
• recent major trauma or surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate angiography	immediate angiography and revascularization	Immediate invasive angiography \< 2 h after randomization
early invasive angiography	early invasive angiography	early invasive angiography 12-72 h after randomization

Primary Outcome Measures

Name	Time	Method
Death and non-fatal recurrent infarction	6 months

Secondary Outcome Measures

Name	Time	Method
Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization	6 months

Trial Locations

Locations (1)

University of Leipzig - Heart Center; 🇩🇪 Leipzig, Germany