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Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI

This study has been completed.
Information provided by:
University of Jena Identifier:
First received: July 8, 2010
Last updated: July 9, 2010
Last verified: July 2010
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.

Condition Intervention Phase
Procedure: percutaneous coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • MACE [ Time Frame: 6 months ]
    composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion

Secondary Outcome Measures:
  • CK and CK-MB [ Time Frame: 48 hours ]
    Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.

Enrollment: 602
Study Start Date: July 2006
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: occluded culprit artery
An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
Procedure: percutaneous coronary intervention
early timing
Other Name: early invasive treatment strategy in NSTEMI
Active Comparator: non-occluded culprit artery
A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.
Procedure: percutaneous coronary intervention
early timing
Other Name: early invasive treatment strategy in NSTEMI

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.

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • participation in another study.
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Please refer to this study by its identifier: NCT01159366

University of Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Jena
Study Chair: Gerhard Schuler, MD, PhD University of Leipzig
  More Information

Responsible Party: Holger Thiele, MD, PhD, University of Leipzig Identifier: NCT01159366     History of Changes
Study First Received: July 8, 2010
Last Updated: July 9, 2010

Keywords provided by University of Jena:
myocardial infarction
coronary occlusion
myocardial revascularization
prognosis processed this record on May 25, 2017