Management tactics for high-risk patients with acute coronary syndrome and multivessel disease
A Prospective Multicenter Randomized Trial: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
This study is testing whether a heart procedure called PCI or a surgery called CABG works better for patients with acute coronary syndrome and multiple blocked arteries to improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me Government |
| Locations | 2 sites (Novosibirsk, Novosibirsk Obl and 1 other locations) |
| Trial ID | NCT06279663 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients experiencing acute coronary syndrome without ST segment elevation who also have multivessel coronary artery disease. Participants will be randomized into two groups to compare the effectiveness of revascularization techniques: percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). The goal is to achieve complete myocardial revascularization, ensuring that no significant coronary artery stenosis remains post-procedure. A total of 460 patients will be enrolled, with each group consisting of 230 patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with high-risk acute coronary syndrome requiring revascularization and suitable for both PCI and CABG.
Not a fit: Patients who do not have acute coronary syndrome or those who are not suitable for either PCI or CABG will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for high-risk patients with acute coronary syndrome, potentially enhancing their recovery and long-term outcomes.
How similar studies have performed: While similar studies have explored revascularization techniques, this specific approach targeting high-risk patients with multivessel disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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) 2. 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). 3. 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%). 4. Signed informed consent 5. Age over 18 years. Exclusion Criteria: 1. Myocardial infarction with ST segment elevation 2. Stable angina pectoris 3. Patients with OSN Killip II-IV class 4. Patients required an immediate PCI procedure (e.g. electrical instability) 5. A history of hemorrhagic stroke one year before the procedure 6. Ischemic stroke or TIA in the last 6 weeks 7. The final stage of chronic renal failure requiring dialysis. 8. Preliminary PCI for any other coronary artery lesion within 1 year prior to randomization. 9. Pre-CABG at any time prior to randomization. 10. 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. 11. 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
Where this trial is running
Novosibirsk, Novosibirsk Obl and 1 other locations
- Anton — Novosibirsk, Novosibirsk Obl, Russia (Recruiting)
- Anton — Novosibirsk, Rechkunovskaya Str., Russia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.