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

University of Leipzig

Status: Withdrawn

Conditions: Non-ST-elevation Myocardial Infarction

Treatments: Procedure: immediate angiography and revascularization; Procedure: early invasive angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT00954668

IDEAL NSTEMI 1

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

immediate angiography

Experimental group

Description:

Immediate invasive angiography \< 2 h after randomization

Treatment:

Procedure: immediate angiography and revascularization

early invasive angiography

Active Comparator group

Description:

early invasive angiography 12-72 h after randomization

Treatment:

Procedure: early invasive angiography