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NCT Number: NCT06279663

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

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.

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Key information

Conditions

Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anton, Novosibirsk, Novosibirsk Obl, Russia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revascularization

Procedure

revascularization

Primary outcomes

  1. Death from any cause

    Time frame: 1 year

    a fatal outcome due to any cause or disease

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

    Time frame: 1 year

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

  3. target LDL level

    Time frame: 1 year

    Achieved target LDL level

Secondary outcomes

  1. Myocardial infarction

    Time frame: 1 year

    Myocardial infarction (Fourth universal definition of myocardial infarction (2018))

  2. Stroke

    Time frame: 1 year

    clinically verified acute cerebrovascular accident of any etiology (hemorrhagic or ischemic)

  3. Repeated unplanned myocardial revascularization

    Time frame: 1 year

    any type of repeated myocardial revascularization by endovascular or cardiac surgery performed in the time period after index revascularization;

  4. Duration of the hospital period

    Time frame: 1 year

    the number of bed days that the patient spent in the clinic in connection with an index event and/or complications arising from the underlying, concomitant diseases, as well as in connection with the treatment.

  5. Intra/perioperative complications

    Time frame: 1 year

    Any intra/perioperative complications (MI, Stroke, hemorrhagic complication, )

  6. Significant hemorrhagic complications (grade 3 or more on the BARC scale)

    Time frame: 1 year

    any bleeding that occurred during or after the index revascularization of the myocardium, leading to a clinically significant decrease in hemoglobin levels, requiring hemotransfusion and/or surgical methods of hemostasis, artery dissection, shunt thrombosis, and other

  7. Questionnaire

    Time frame: 1 year

    SF-36 Quality of Life Questionnaire and Rose Questionn

Sponsors and collaborators

Lead sponsor

Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me

Other Gov

Collaborators

  • Kemerovo Cardiology Center, Tarasov Roman Sergeevich
  • Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich

Registry information

Official study 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

Acronym: NSTE-ACSMT

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 28, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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