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

NCT ID: NCT00954668

Last Updated: 2018-07-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2009-01-01

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.

Conditions

Non-ST-elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

immediate angiography

Immediate invasive angiography \< 2 h after randomization

Group Type: EXPERIMENTAL

immediate angiography and revascularization

Intervention Type: PROCEDURE

immediate angiography \< 2 hours after randomization

early invasive angiography

early invasive angiography 12-72 h after randomization

Group Type: ACTIVE_COMPARATOR

early invasive angiography

Intervention Type: PROCEDURE

early invasive angiography 12-72 h after randomization

Interventions

immediate angiography and revascularization

immediate angiography \< 2 hours after randomization

Intervention Type: PROCEDURE

early invasive angiography

early invasive angiography 12-72 h after randomization

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Holger Thiele

Clinical Professor Prof. Dr. Holger Thiele

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holger Thiele, MD

Role: STUDY_CHAIR

Heart Center Leipzig - University Hospital

Uwe Zeymer, MD

Role: STUDY_DIRECTOR

Institut für Herzinfarktforschung

Locations

University of Leipzig - Heart Center

Leipzig, , Germany

Countries

Germany

Other Identifiers

IDEAL NSTEMI 1

Identifier Type: -

Identifier Source: org_study_id