Study Stopped
No funding
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
IDEAL NSTEMI
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 7, 2009
CompletedJuly 6, 2018
July 1, 2018
Same day
August 6, 2009
July 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death and non-fatal recurrent infarction
6 months
Secondary Outcomes (1)
Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization
6 months
Study Arms (2)
immediate angiography
EXPERIMENTALImmediate invasive angiography \< 2 h after randomization
early invasive angiography
ACTIVE COMPARATORearly invasive angiography 12-72 h after randomization
Interventions
immediate angiography \< 2 hours after randomization
early invasive angiography 12-72 h after randomization
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leipziglead
- Stiftung Institut fuer Herzinfarktforschungcollaborator
Study Sites (1)
University of Leipzig - Heart Center
Leipzig, 04289, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Holger Thiele, MD
Heart Center Leipzig - University Hospital
- STUDY DIRECTOR
Uwe Zeymer, MD
Institut für Herzinfarktforschung
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor Prof. Dr. Holger Thiele
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 7, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
July 6, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share