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CompletedNCT01332591Prague-13Updated Jan 1, 2015

Multivessel Disease Diagnosed at the Time of PPCI for STEMI: Complete Revascularization Versus Conservative Strategy.

An interventional study of Percutaneous coronary intervention in Coronary Artery Stenosis, sponsored by St. Anne's University Hospital Brno, Czech Republic. Completed at 1 site in Czech Republic. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-01.

Sponsored by St. Anne's University Hospital Brno, Czech Republic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Read the detailed description

Introduction:

Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.

Aim of study:

The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.

Hypothesis:

Our hypothesis is that complete staged revascularization of significant stenoses of the coronary arteries will improve the long-term prognosis in patients after PPCI as compared to conservative management.

02

Conditions studied

  • Coronary Artery Stenosis

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Keywords

  • STEMI, primary PCI, non-infarct, non-culprit lesion, CABG
03

In context

Coronary Stenosis

302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.

This study's enrollment of 213 is close to the median of 200 across 160 interventional studies indexed under Coronary Stenosis.

Browse Coronary Stenosis studies →

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with acute myocardial infarction with ST segment elevation (STEMI)
  • Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
  • One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
  • Enrollment ≥48 hours following onset of symptoms

Exclusion criteria

Exclusion Criteria:

  • Stenosis of the left main of left coronary artery ≥ 50%
  • Hemodynamically significant valvular disease
  • Patients in cardiogenic shock during STEMI
  • Hemodynamic instability
  • Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
213 participants (actual)

Study arms

  • Active comparator
    Complete revascularization

    Percutaneous coronary intervention of "non-infarct" coronary arteries

    Procedure: Percutaneous coronary intervention

  • No intervention
    Conservative management

    standard guideline-based medical therapy

Interventions

  • ProcedurePercutaneous coronary intervention

    PCI of significant stenoses of "non-infarct" coronary arteries

06

What researchers measure

Primary outcomes

  1. composite endpoint of death, nonfatal acute myocardial infarction and stroke

    Time frame: 2 years

Secondary outcomes

  1. cardiovascular death

    Time frame: 2 years

  2. recurrent myocardial infarction

    Time frame: 2 years

  3. target vessel failure

    progression of studied stenosis of non-culprit artery

    Time frame: 2 years

  4. stroke

    Time frame: 2 years

  5. hospitalization for heart failure

    Time frame: 2 years

  6. changes of left ventricular ejection fraction

    Time frame: 2 years

  7. hospitalization for unstable angina pectoris

    Time frame: 2 years

  8. outcomes of questionnaire regarding angina pectoris

    Time frame: 2 years

  9. target vessel revascularization

    non infarct artery

    Time frame: 2 years

  10. target lesion revascularization

    non infarct artery

    Time frame: 2 years

07

Study locations

1 site
  • Department of Cardioangiology, St. Anne University Hospital
    Brno, 65691, Czech Republic
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01332591
Lead sponsor
St. Anne's University Hospital Brno, Czech Republic
Collaborators
Bulgarian Cardiac Institute, Tomas Bata Hospital, Czech Republic
Responsible party
Ota Hlinomaz, MD, PhD (Ota Hlinomaz, MD, PhD, St. Anne's University Hospital Brno, Czech Republic) — Principal investigator
First posted
Apr 11, 2011
Start date
Sep 2008
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 1, 2015

Study contacts

Ota Hlinomaz, MD, PhD
principal investigator · +420604273627

Oversight

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

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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