Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
1 other identifier
interventional
602
1 country
1
Brief Summary
It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Longer than P75 for phase_4
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
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 9, 2010
CompletedJuly 12, 2010
July 1, 2010
3.4 years
July 8, 2010
July 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
6 months
Secondary Outcomes (1)
CK and CK-MB
48 hours
Study Arms (2)
occluded culprit artery
ACTIVE COMPARATORAn occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
non-occluded culprit artery
ACTIVE COMPARATORA non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.
Interventions
early timing
Eligibility Criteria
You may qualify if:
- age between 18 and 90 years,
- onset of angina pectoris at rest \<24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting \<24 h,
- elevated troponin T ≥0.03 µg/L and
- written informed consent.
You may not qualify if:
- persistent angina,
- ST-segment elevation myocardial infarction (STEMI),
- hemodynamic instability including cardiogenic shock,
- oral anticoagulation therapy,
- contraindications for glycoprotein IIb/IIIa inhibitors,
- other disease with life expectancy \<6 months,
- known coagulopathy,
- pregnancy,
- other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,
- no ability to consent, and
- participation in another study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Leipzig
Leipzig, 04289, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gerhard Schuler, MD, PhD
University of Leipzig
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 8, 2010
First Posted
July 9, 2010
Study Start
July 1, 2006
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
July 12, 2010
Record last verified: 2010-07