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

U

University of Jena

Status and phase

Completed
Phase 4

Conditions

NSTEMI

Treatments

Procedure: percutaneous coronary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01159366
NCT00402675

Details and patient eligibility

About

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.

Full 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.

Enrollment

602 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

602 participants in 2 patient groups

occluded culprit artery
Active Comparator group
Description:
An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.
Treatment:
Procedure: percutaneous coronary intervention
non-occluded culprit artery
Active Comparator group
Description:
A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.
Treatment:
Procedure: percutaneous coronary intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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