Management Tactics for Patients High Risk With Acute Coro... | NCT06279663

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

NCT06279663

Sponsor

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

Status

Recruiting

Last Update Posted

Mar 13, 2024Actual

Enrollment

460Estimated

Phase

Not Applicable

Conditions

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

Interventions

Revascularization

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 29, 2024Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Feb 15, 2024

First Submission Date that Met QC Criteria

Feb 22, 2024

First Posted Date

Feb 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2024

Last Update Posted Date

Mar 13, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Obedinskiy Anton Andreyevich, Obedinskiy Anton Andreyevich, Federal State Budgetary Institution National Medical Research Center named after academician E.N. MePrincipal Investigator

Lead Sponsor

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

Collaborators

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

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

460Estimated

Label	Type	Description	Intervention Names
PCI	Active Comparator	complete revascularization	Procedure: Revascularization
CABG	Active Comparator		Procedure: Revascularization

Name	Type	Description	Arm Group Labels	Other Names
Revascularization	Procedure	revascularization	CABG PCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Myocardial infarction	Myocardial infarction (Fourth universal definition of myocardial infarction (2018))	1 year
Stroke	clinically verified acute cerebrovascular accident of any etiology (hemorrhagic or ischemic)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms