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

July 8, 2010
July 9, 2010
July 2006
December 2009   (final data collection date for primary outcome measure)
MACE [ Time Frame: 6 months ] [ Designated as safety issue: No ]
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
Same as current
Complete list of historical versions of study NCT01159366 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
NSTEMI
Procedure: percutaneous coronary intervention
early timing
Other Name: early invasive treatment strategy in NSTEMI
  • Active Comparator: occluded culprit artery
    An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
    Intervention: Procedure: percutaneous coronary intervention
  • 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.
    Intervention: Procedure: percutaneous coronary intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
602
January 2010
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01159366
NCT00402675
Yes
Holger Thiele, MD, PhD, University of Leipzig
University of Jena
Not Provided
Study Chair: Gerhard Schuler, MD, PhD University of Leipzig
University of Jena
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP