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

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
Collaborator:
Stiftung Institut fuer Herzinfarktforschung
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00954668
First received: August 6, 2009
Last updated: June 24, 2010
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-ST-Elevation Myocardial Infarction
 Procedure: immediate angiography and revascularization
Procedure: early invasive angiography
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Death and non-fatal recurrent infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2100
Arms Assigned Interventions
Experimental: immediate angiography
Immediate invasive angiography < 2 h after randomization
 Procedure: immediate angiography and revascularization
immediate angiography < 2 hours after randomization
Active Comparator: early invasive angiography
early invasive angiography 12-72 h after randomization
 Procedure: early invasive angiography
early invasive angiography 12-72 h after randomization

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954668

Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Stiftung Institut fuer Herzinfarktforschung
Investigators
Study Chair: Holger Thiele, MD University of Leipzig
Study Director: Uwe Zeymer, MD Institut für Herzinfarktforschung
  More Information

No publications provided

Responsible Party: Holger Thiele, University of Leipzig - Heart Center
ClinicalTrials.gov Identifier: NCT00954668     History of Changes
Other Study ID Numbers: IDEAL NSTEMI 1, DFG application no. 29
Study First Received: August 6, 2009
Last Updated: June 24, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
Non-ST-elevation myocardial infarction
angiography
percutaneous coronary intervention
timing

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013