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临床试验/NCT04489355
NCT04489355已完成不适用

Assessment of Risks and Outcomes of Surgical Intervention in Patients With Ischemic Cardiomyopathy in the Early and Long-term Postoperative Period, Selection of Optimal Surgical and Surgical Treatment

Tomsk National Research Medical Center of the Russian Academy of Sciences1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2013年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
1
主要终点
Cardiac death

研究概览

简要总结

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.

详细描述

The aim of the study is to develop a new personalized approach to diagnostics and surgical treatment of patients with ischemic cardiomyopathy.

Research Objectives:

  1. To assess the prognostic values of scintigraphic indicators of myocardial perfusion, contractility, and metabolism in patients with ischemic cardiomyopathy in regard to the development of cardiac remodeling and adverse cardiovascular events in the mid term after surgery.
  2. To assess the prognostic values of parameters of cardiac magnetic resonance imaging (cMRI) allowing to predict the risks of surgical intervention and chronic heart failure progression in patients with ischemic cardiomyopathy.
  3. To analyze the relationships between the structural and functional state of the myocardium and the effectiveness of various types of surgery in patients with ischemic cardiomyopathy. The structural and functional state of the myocardium is assessed by the instrumental methods including myocardial scintigraphy, cMRI, stress echocardiography, spiroergometry, and intraoperative fluometry.
  4. To identify the myocardial biopsy-based predictors of adverse outcome in patients with ischemic cardiomyopathy in the early and mid term postoperative period in patients with ischemic cardiomyopathy.
  5. To study the relationships between tissue and molecular biomarkers, severity of ischemic cardiomyopathy, and the outcomes in patients with ischemic cardiomyopathy in the postoperative period.
  6. To introduce new and to optimize existing methods of surgical treatment in patients with ischemic cardiomyopathy.
  7. To develop an algorithmic model for assessing the risks and predicting outcomes of surgical intervention in patients with ischemic cardiomyopathy in the postoperative period.

Methods:

  1. Clinical status of the patient: collection of complaints, medical history, physical examination, assessment of anthropometric indicators (measurement of body weight, height, BMI), and demographic indicators before and in the control period after surgical treatment.
  2. General clinical examination: standard 12-lead ECG, general urine analysis, general blood analysis, blood chemistry, coagulation, chest x-ray, ultrasound of the carotid and femoral arteries.
  3. Echocardiography: determination of the type of aneurysm according to Di Donato; measuring the distance between the papillary muscles of the left ventricle; assessing the depth of co-optation of the mitral valve cusps; measuring Vena contracta; measuring the radius of the proximal regurgitation zone, cm; Effective Regurgitant Orifice Area (EROA, cm2); assessing systolic index and sphericity index. Stress echocardiography with dobutamine. Before stress echocardiography on a Vivid E9 ultrasound system (GE, Healthcare), continuous intravenous administration of dobutamine HEXAL, starting from 5 μg/kg/min and increasing its dose every 3 minutes to 10, 15, 20, 30, and 40 μg/kg.
  4. Coronarography for assessing the anatomy and condition of the coronary pool using an angiographic unit (Axiom Artis/Innova 2121-IQ (General Electric, USA)).
  5. Contrast-enhanced cMRI to assess the following parameters:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Cardiac death

时间窗: 12 months

Cardiac death, %

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

时间窗: 12 months

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

次要结局

  • Number of participants with increased exercise tolerance(12 months)

研究者

研究点 (1)

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