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

University of Leipzig

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Non-ST-elevation Myocardial Infarction

Interventions

immediate angiography and revascularizationPROCEDURE

immediate angiography \< 2 hours after randomization

early invasive angiographyPROCEDURE

early invasive angiography 12-72 h after randomization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Leipzig - Heart Center

Leipzig, Germany

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

Time frame: 6 months

Data from ClinicalTrials.gov

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