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

Non-ST-elevation Myocardial Infarction Clinical Trial

— IDEAL NSTEMI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00954668
• Other study ID #: IDEAL NSTEMI 1
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2009
• Est. completion date: January 1, 2009

Study information

• Verified date: July 2018
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2009
• Est. primary completion date: January 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• Non-ST-elevation Myocardial Infarction

Intervention

Procedure:
• immediate angiography and revascularization
immediate angiography < 2 hours after randomization
• early invasive angiography
early invasive angiography 12-72 h after randomization

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
University of Leipzig	Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death and non-fatal recurrent infarction		6 months
Secondary	Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization		6 months