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Recruiting NCT06279663

Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

No phase Interventional Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Revascularization.
Who it may be relevant to
Registry conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease

Overview

The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG.

Interventions

  • Procedure Revascularization
    revascularization

Primary outcome measures

  • Death from any cause [Time frame: 1 year]
  • Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization) [Time frame: 1 year]
  • target LDL level [Time frame: 1 year]
Secondary outcome measures (7)
  • Myocardial infarction [Time frame: 1 year]
  • Stroke [Time frame: 1 year]
  • Repeated unplanned myocardial revascularization [Time frame: 1 year]
  • Duration of the hospital period [Time frame: 1 year]
  • Intra/perioperative complications [Time frame: 1 year]
  • Significant hemorrhagic complications (grade 3 or more on the BARC scale) [Time frame: 1 year]
  • Questionnaire [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Acute coronary syndrome without ST segment elevation of high risk: unstable angina pectoris or myocardial infarction requiring revascularization within 24 hours based on the risk of an unfavorable outcome (increase or decrease in the concentration of cardiac troponin in the blood that meet the criteria of MI; dynamic ST segment displacement or changes in T; risk on the GRACE scale >140 points)
  • The patient is suitable for both CABG and PCI, confirmed by an interventional cardiologist and surgeon (multivessel lesion with a Sintax score of 23-32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery).
  • Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of > 2.5 mm, that is, residual coronary artery stenosis of no more than 60%).
  • Signed informed consent
  • Age over 18 years.

Exclusion criteria

  • Myocardial infarction with ST segment elevation
  • Stable angina pectoris
  • Patients with OSN Killip II-IV class
  • Patients required an immediate PCI procedure (e.g. electrical instability)
  • A history of hemorrhagic stroke one year before the procedure
  • Ischemic stroke or TIA in the last 6 weeks
  • The final stage of chronic renal failure requiring dialysis.
  • Preliminary PCI for any other coronary artery lesion within 1 year prior to randomization.
  • Pre-CABG at any time prior to randomization.
  • The need for concomitant cardiac surgery, except for CABG (for example, valve surgery, aortic repair, etc.). Patients who require additional surgery (cardiological or extra-cardiac) for 1 year.
  • Non-cardiac concomitant diseases with a life expectancy of less than 1 year (for example, oncological diseases).

13\. The left ventricular ejection fraction is less than 40%. 14. Severe degree of COPD

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 2 centers
  • Anton — Novosibirsk
  • Anton — Novosibirsk

Identifiers

NCT: NCT06279663 · NSTE-ACS Multivessel Trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗