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OpenTrials
Completed

NCT Number: NCT01159366

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

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.

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Key information

Conditions

NSTEMI Cardiovascular Diseases Coronary Disease Coronary Occlusion Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Leipzig

Leipzig, 04289, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous coronary intervention

Procedure

early timing

Other names: early invasive treatment strategy in NSTEMI

Primary outcomes

  1. MACE

    Time frame: 6 months

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jul 9, 2010
Registry last updated
Jul 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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