CClinicalTrials.gg
CompletedNCT01159366Updated Jul 12, 2010

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

A Phase 4 interventional study of percutaneous coronary intervention in NSTEMI, sponsored by University of Jena. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2010-07-12.

Sponsored by University of Jena · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
602
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • NSTEMI

Keywords

  • myocardial infarction
  • coronary occlusion
  • myocardial revascularization
  • collaterals
  • prognosis
03

In context

Non-ST Elevated Myocardial Infarction

146 studies on the registry are indexed under Non-ST Elevated Myocardial Infarction; 40 are open to participants now.

This study's enrollment of 602 is above the median of 300 across 82 interventional studies indexed under Non-ST Elevated Myocardial Infarction.

Browse Non-ST Elevated Myocardial Infarction studies →

Lead sponsor

University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
602 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Procedurepercutaneous coronary intervention

    early timing

    Also known as: early invasive treatment strategy in NSTEMI

06

What researchers measure

Primary outcomes

  1. MACE

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

    Time frame: 6 months

Secondary outcomes

  1. CK and CK-MB

    Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.

    Time frame: 48 hours

07

Study locations

1 site
  • University of Leipzig
    Leipzig, 04289, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01159366
Lead sponsor
University of Jena
First posted
Jul 9, 2010
Start date
Jul 2006
Primary completion
Dec 2009
Completion
Jan 2010
Last update
Jul 12, 2010

Study contacts

Gerhard Schuler, MD, PhD
study chair · University of Leipzig

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion