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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00954668

Acronym

IDEAL NSTEMI

Enrollment

Registered

2009-08-07

Start date

2009-01-01

Completion date

2009-01-01

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-ST-elevation Myocardial Infarction

Keywords

Non-ST-elevation myocardial infarction, angiography, percutaneous coronary intervention, timing

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.

Interventions

PROCEDUREimmediate angiography and revascularization

immediate angiography \< 2 hours after randomization

PROCEDUREearly invasive angiography

early invasive angiography 12-72 h after randomization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Death and non-fatal recurrent infarction	6 months

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026