The Effectiveness of Surgical Treatment of Patients With Ischemic Cardiomyopathy (NCT04489355) | Clinical Trial Compass
CompletedNot Applicable
The Effectiveness of Surgical Treatment of Patients With Ischemic Cardiomyopathy
Russia260 participantsStarted 2013-01-28
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with postoperative left ventricular remodeling according to echocardiography.
Timeframe: 12 months
2
Cardiac death
Timeframe: 12 months
Trial details
NCT IDNCT04489355
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences