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

July 9, 2010 updated by: University of Jena

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

602

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • early invasive treatment strategy in NSTEMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 6 months
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Study Chair: Gerhard Schuler, MD, PhD, University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (ESTIMATE)

July 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 12, 2010

Last Update Submitted That Met QC Criteria

July 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT00402675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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