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临床试验/NCT05913778
NCT05913778已完成不适用

Long-term Effects of Enhanced External Counterpulsation on the Structural and Functional State of Blood Vessels in Patients With Coronary Heart Disease and Chronic Heart Failure

I.M. Sechenov First Moscow State Medical University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月10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
100
试验地点
2
主要终点
Composite primary endpoint

研究概览

简要总结

Enhanced external counterpulsation (EECP) is an effective non-invasive treatment in patients with coronary artery disease (CAD) which complicated by chronic heart failure (CHF).

Aim: to study the long-term effects of treatment with enhanced external counterpulsation on the structural and functional state of the vascular bed in patients with stable CAD complicated by CHF.

Patients (n=100) with verified stable CAD (class 2-3 angina) complicated by CHF (NYHA class 2-3) and receiving optimal drug therapy included in open randomized study.

Primary randomization (2:1) + secondary randomization (1:1).

  • SHAM-counterpulsation group (ECP-SHAM; compression pressure 80 mm Hg; 35 procedures, 1 hour each);
  • Active counterpulsation group (ECP35; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 1 course per year;
  • Active counterpulsation group (ECP70; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 2 courses per year.

Duration of observation is 3 years. Stages of examination: after 3, 6, 12, 24, 36 months (after 3, 6, 12 months for the ECP-SHAM group).

Primary endpoint: combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death.

Secondary endpoints: changes in exercise tolerance, a needing for antianginal therapy, frequency of angina episodes.

Objectives: to study the dynamics of the structural and functional state of the vascular bed (applanation tonometry, photoplethysmography, computer nailfold videocapillaroscopy), the dynamics of the clinical status (Clinical Status Assessment Scale), the dynamics of exercise tolerance (6-minute walk test), the dynamics of the quality of life of patients ( questionnaires SF36 and MLHFQ) in the ECP35 and ECP70 groups at baseline, at the end of the first course, after 6 months, 1, 2, and 3 years, and in the ECPSHAM group at baseline, at the end of the first course, after 6 and 12 months; (2) To investigate the impact of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, death) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints.

Expected outcome of the study: Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional state of the vascular bed, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF.

详细描述

  1. Topic relevance

The dominant positions of coronary artery disease (CAD) in the structure of morbidity, disability and mortality among patients with cardiovascular diseases determine the social significance of this disease. With an increase in the incidence of cardiovascular diseases from 2.483 million cases in 2000 to 4.784 million cases in 2018 (an increase of 193%), there is also an increase in newly diagnosed cases of CAD by 47%. The mortality rate from circulatory diseases in Russia over the past 15 years has decreased from 927.5 to 587.6 per 100,000 population. Achievements of modern medicine (optimization of pharmacotherapy and an increase in the number of revascularization procedures) have contributed to an improvement in the survival rates of patients with CAD. However, with an increase in life expectancy, the economic burden of atherosclerotic diseases and the need to improve the quality of life of such patients increase.

Taking into account the insufficient effect of a conservative strategy in patients with severe stenoses in the coronary bed, a clear increase in the number of revascularization procedures has been observed over the past two decades. However, the limited duration of the effective functioning of stents and shunts, as well as the lack of proven benefits in terms of influencing the prognosis compared to conservative measures do not allow to fully rely on this strategy as well. In the population, there is an accumulation of the proportion of people with refractory angina pectoris, with insufficient effectiveness of the use of conservative and invasive strategies. The basis of this population is patients with progression of multivessel coronary atherosclerosis, microvascular disease, incomplete myocardial revascularization, stenosis or occlusion of shunts / stents, and patients who cannot undergo coronary bypass surgery or stenting, including repeated ones, for various other reasons. In addition, the course of coronary artery disease in such patients is often complicated by chronic heart failure (CHF), which further reduces the quality of life of patients and the prognosis. This determines the search for additional methods of treatment for these patients, which can enhance the effect of conservative and invasive strategies.

Enhanced external counterpulsation (EECP) is an effective non-invasive and atraumatic treatment for patients with coronary artery disease, including complicated CHF. Preference should be given to this method in patients with severe diffuse lesions of the coronary arteries, in case of impossibility or high risk of myocardial revascularization, as well as in case of complication of heart failure. The influence of this method on the contractility of the heart, exercise tolerance and quality of life of these patients has been studied quite well. However, the long-term effects of EECP on the structural and functional state of the vascular bed (the main targets of this method) in patients with coronary artery disease complicated by CHF remain little studied. 2. The novelty of the proposed topic on literary sources and patent documentation. No similarly designed studies were found in the available literature. Scientific novelty It is planned to study long-term vascular effects, the impact on exercise tolerance, quality of life, the frequency of serious adverse events, the impact on the prognosis during the treatment of EECP patients with stable CAD complicated by CHF. It is planned to expand the possible indications for EECP, optimize the treatment of EECP in patients with refractory angina and heart failure. 3. Purpose and objectives of the planned research. Purpose of the study - To study the long-term effects of treatment with EECP on the structural and functional vascular state in patients with stable CAD complicated by CHF.

Research objectives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-75 years
  • Verified CAD (class 2-3, stable angina) complicated by CHF (NYHA class 2-3)
  • Optimal medical treatment
  • Signed voluntary informed consent to participate in the study

排除标准

  • Contraindications to treatment with EECP: recent (2-4 weeks ago) catheterization of arterial vessels; cardiac arrhythmias that can affect the synchronization of counterpulsation with the ECG; decompensated heart failure; left ventricular ejection fraction less than 30%; severe aortic insufficiency; critical ischemia of the arteries of the lower extremities; thrombosis / thrombophlebitis of the veins of the lower extremities; uncontrolled arterial hypertension (>180/110mm Hg); high pulmonary hypertension (grade 2-3; >45 mm Hg); coagulopathy, treatment with anticoagulants with prothrombin time >15 sec/INR >3; pregnancy; aneurysm of the thoracic or abdominal aorta requiring surgical treatment.
  • Refusal of the patient from further participation in the study.

结局指标

主要结局

Composite primary endpoint

时间窗: 12 months, 24 months, 36 months

combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death

次要结局

  • Angina episodes(12 months, 24 months, 36 months)
  • Exercise tolerance(3 months, 6 months, 12 months, 24 months, 36 months)
  • Antianginal therapy(12 months, 24 months, 36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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