NCT06279663Recruiting
Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery 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
Source: ClinicalTrials.gov · Last updated 13 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 460 (estimated)
- First submitted
- 15 Feb 2024
- Start date
- 29 Feb 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me
- Diseases
- Coronary artery disease
- NCT number
- NCT06279663
What you commit to
- Study type: Interventional
- Planned participants: 460
- From 29 Feb 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Myocardial infarction with ST segment elevation
- Stable angina pectoris
- 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.
Lab values
- 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
Other
- Patients with OSN Killip II-IV class
- Patients required an immediate PCI procedure (e.g. electrical instability)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anton Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.