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

Phase 4

Completed

• Conditions: NSTEMI
• Interventions: Procedure: percutaneous coronary intervention

• Registration Number: NCT01159366
• Lead Sponsor: University of Jena

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2010-07
• Study First Submitted: 2010-07-08
• Study First Submitted QC: 2010-07-08
• Study First Posted: 2010-07-09
• Last Update Submitted: 2010-07-09
• Last Update Posted: 2010-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
occluded culprit artery	percutaneous coronary intervention	An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
non-occluded culprit artery	percutaneous coronary intervention	A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.

Primary Outcome Measures

Name	Time	Method
MACE	6 months	composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion

Secondary Outcome Measures

Name	Time	Method
CK and CK-MB	48 hours	Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.

Trial Locations

Locations (1)

University of Leipzig; 🇩🇪 Leipzig, Germany