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

Study 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.

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

Conditions
-----------------
Non-ST-elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: immediate angiography and revascularization
* Procedure: early invasive angiography


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate angiography<br>Immediate invasive angiography < 2 h after randomization | Procedure: immediate angiography and revascularization<br>* immediate angiography < 2 hours after randomization<br>|
| Active Comparator: early invasive angiography<br>early invasive angiography 12-72 h after randomization | Procedure: early invasive angiography<br>* early invasive angiography 12-72 h after randomization<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and non-fatal recurrent infarction |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-ST-elevation myocardial infarction, angiography, percutaneous coronary intervention, timing