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

NCT06279663 | Recruiting DMC

• 1 other identifier: NSTE-ACS Multivessel Trial
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients

Outcome Measures

Primary Outcomes (3)

• Death from any cause

  a fatal outcome due to any cause or disease

  1 year

• Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization)

  Death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization.

  1 year

• target LDL level

  Achieved target LDL level

  1 year

Secondary Outcomes (7)

• Myocardial infarction

  1 year

• Stroke

  1 year

• Repeated unplanned myocardial revascularization

  1 year

• Duration of the hospital period

  1 year

• Intra/perioperative complications

  1 year

Study Arms (2)

PCI

ACTIVE COMPARATOR

complete revascularization

Procedure: Revascularization

CABG

ACTIVE COMPARATOR

Procedure: Revascularization

Interventions

Revascularization PROCEDURE

revascularization

CABG; PCI

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me: lead
• Kemerovo Cardiology Center, Tarasov Roman Sergeevich: collaborator
• Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich: collaborator

Study Sites (2)

Anton

Novosibirsk, Novosibirsk Obl, 630055, Russia

RECRUITING

Anton

Novosibirsk, Rechkunovskaya Str., 630055, Russia

RECRUITING

MeSH Terms

Conditions

Angina, Unstable

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obedinskiy Anton Andreyevich

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 28, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

RU (2)