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Clinical Trials/NCT01159366
NCT01159366
Completed
Phase 4

Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL

University of Jena1 site in 1 country602 target enrollmentJuly 2006
ConditionsNSTEMI

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
NSTEMI
Sponsor
University of Jena
Enrollment
602
Locations
1
Primary Endpoint
MACE
Status
Completed
Last Updated
15 years ago

Overview

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.

Detailed Description

We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
January 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University of Jena

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

MACE

Time Frame: 6 months

composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion

Secondary Outcomes

  • CK and CK-MB(48 hours)

Study Sites (1)

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