The Effectiveness of Surgical Treatment of Patients With Ischemic Cardiomyopathy

NCT04489355 | Completed DMC

• 1 other identifier: CRI-02NR
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The study focuses on the development of a new personalized approach to diagnostics and surgical treatment of patients with ischemic cardiomyopathy. The algorithm for selection of patients for certain type of cardiac surgery will be developed. The models for prediction of the risks and outcomes of cardiac surgery will be elaborated to reduce the rate of complications in the early and long-term postoperative period in patients with ischemic cardiomyopathy. Imaging modalities, methods for assessement of structural and functional state of the myocardium, biochemistry testing, immunohistochemical examination, and myocardial biopsy studies will be used to achieve these goals.

Conditions

Ischemic Cardiomyopathy; Cardiovascular Diseases; Chronic Heart Failure

Keywords

Chronic heart failure; Ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Number of participants with postoperative left ventricular remodeling according to echocardiography.

  Number of participants with a decrease in left ventricular end-systolic volume by 15% or more.

  12 months

• Cardiac death

  Cardiac death, %

  12 months

Secondary Outcomes (1)

• Number of participants with increased exercise tolerance

  12 months

Study Arms (4)

CABG

The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG)

Procedure: coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)

CABG with SVR

The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR)

Procedure: coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)

CABG with mitral repair

The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with and mitral repair (MR)

Procedure: coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)

CABG with SVR and mitral repair

The patients with ischemic cardiomyopathy underwent coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)

Procedure: coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)

Interventions

coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR) PROCEDURE

CABG; CABG with SVR; CABG with SVR and mitral repair; CABG with mitral repair

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ischemic cardiomyopathy with indications for cardiac surgery

You may qualify if:

• left ventricular ejection fraction less than or equal to 40%; a history of myocardial infarction with a duration of more than 3 months and/or stenosis of more than 75% of the trunk of the left coronary artery, or proximal stenosis of the anterior descending artery and/or stenosis of more than 75% of two or more coronary arteries; final LV systolic index greater than or equal to 60 ml / m2 according to echocardiography, age 18-70 years

You may not qualify if:

• the presence of organic heart defects of rheumatic and infectious etiology; acute myocardial infarction; less than 3 months after acute coronary or cerebrovascular events; severe pulmonary hypertension not associated with mitral regurgitation (above 75 mmHg); contraindications for operations with cardiopulmonary bypass; chronic alcoholism (including alcoholic damage to the heart), mental disorders; severe course of bronchial asthma, chronic obstructive pulmonary disease in the acute stage; oncological diseases in the terminal stage, refusal of the patient or relatives to participate in the study.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, 634012, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Myocardial biopsy: it is planned to intraoperatively collect myocardial biopsy samples from patients with ischemic cardiomyopathy. In case of aneurysmectomy and myocardial biopsy in the middle parts of the left ventricle of the anterior, posterior, lateral walls and interventricular septum on the side of the endocardium, the wall of the aneurysm and the portion of the right atrial appendage, in the absence of an aneurysm, only the portion of the right atrial appendage.

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Vladimir M Shipulin, MD, PhD

  Cardiology Research Institute, Tomsk NRMC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: January 28, 2013
• Primary Completion: January 28, 2023
• Study Completion: May 1, 2024
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)