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

This study has been completed.
Sponsor:
Information provided by:
University of Jena
ClinicalTrials.gov Identifier:
NCT01159366
First received: July 8, 2010
Last updated: July 9, 2010
Last verified: July 2010
  Purpose

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
NSTEMI
Procedure: percutaneous coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • MACE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • participation in another study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159366

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

No publications provided

Responsible Party: Holger Thiele, MD, PhD, University of Leipzig
ClinicalTrials.gov Identifier: NCT01159366     History of Changes
Other Study ID Numbers: NCT00402675
Study First Received: July 8, 2010
Last Updated: July 9, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Jena:
myocardial infarction
coronary occlusion
myocardial revascularization
collaterals
prognosis

ClinicalTrials.gov processed this record on April 16, 2014