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

NCT ID: NCT01159366

Last Updated: 2010-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 602 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2010-01-31

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.

Conditions

NSTEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

occluded culprit artery

An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.

Group Type: ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type: PROCEDURE

early timing

non-occluded culprit artery

A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.

Group Type: ACTIVE_COMPARATOR

percutaneous coronary intervention

Intervention Type: PROCEDURE

early timing

Interventions

percutaneous coronary intervention

early timing

Intervention Type: PROCEDURE

Other Intervention Names

early invasive treatment strategy in NSTEMI

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

University of Leipzig

Principal Investigators

Gerhard Schuler, MD, PhD

Role: STUDY_CHAIR

University of Leipzig

Locations

University of Leipzig

Leipzig, , Germany

Countries

Germany

Other Identifiers

NCT00402675

Identifier Type: -

Identifier Source: org_study_id