Actively Recruiting
Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
Led by Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me · Updated on 2024-03-13
460
Participants Needed
2
Research Sites
304 weeks
Total Duration
On this page
Sponsors
F
Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me
Lead Sponsor
K
Kemerovo Cardiology Center, Tarasov Roman Sergeevich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years
- Acute coronary syndrome without ST segment elevation of high risk requiring revascularization within 24 hours
- Suitable for both CABG and PCI confirmed by an interventional cardiologist and surgeon
- Multivessel coronary artery lesion with Syntax Score 23-32 and significant damage to key arteries
- Complete myocardial revascularization planned with residual artery stenosis of no more than 60%
- Signed informed consent
You will not qualify if you...
- Myocardial infarction with ST segment elevation
- Stable angina pectoris
- Patients with congestive heart failure Killip class II-IV
- Immediate PCI procedure required due to electrical instability
- History of hemorrhagic stroke within 1 year
- Ischemic stroke or transient ischemic attack in the last 6 weeks
- End-stage chronic kidney failure requiring dialysis
- PCI for any coronary artery lesion within 1 year prior to randomization
- Previous CABG surgery at any time prior to randomization
- Need for additional cardiac surgery besides CABG within 1 year
- Non-cardiac diseases with life expectancy less than 1 year (e.g., cancer)
- Left ventricular ejection fraction below 40%
- Severe chronic obstructive pulmonary disease
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Anton
Novosibirsk, Novosibirsk Obl, Russia, 630055
Actively Recruiting
2
Anton
Novosibirsk, Rechkunovskaya Str., Russia, 630055
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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