Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05913778
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-06-01
Brief Title:
Long-tErm Effects of Enhanced eXternal CountErpuLsation
Sponsor:
IM Sechenov First Moscow State Medical University
Organization:
IM Sechenov First Moscow State Medical University
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXCEL
Brief Summary:
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 n100 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 21 secondary randomization 11
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 CADCHF 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 CADCHF 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
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 n100 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 21 secondary randomization 11
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 CADCHF 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 CADCHF 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
Detailed Description:
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 2483 million cases in 2000 to 4784 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 9275 to 5876 per 100000 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
To study the dynamics of the structural and functional vascular state applanation tonometry photoplethysmography computer nailfold capillaroscopy in active EECP groups 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year initially according to at the end of the course after 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of the clinical status Clinical State Assessment Scale in the groups of active EECP 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year initially at the end of the course after 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of exercise tolerance 6-minute walk test in active EECP groups 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year initially at the end of the course after 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of the quality of life of patients SF36 and MLHFQ questionnaires in the groups of active EECP 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year through the baseline at the end of the course 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of the frequency of angina pectoris episodes the need for antianginal drugs the frequency of vascular events hospitalizations for coronary artery disease CHF deaths in active EECP groups 220-280 mm Hg 35 procedures for 2 or 1 course per year and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures during the observation period
To study the effect of EECP on the incidence of primary vascular events hospitalizations for CADCHF deaths and secondary frequency of angina episodes need for antianginal drugs exercise tolerance endpoints
Perform a correlation analysis between EECP treatment parameters number of procedures and duration of treatment with the characteristics under study vascular and clinical effects
4 Planned type of scientific research The study is open prospective randomized controlled in parallel groups
5 Object of study and the planned number of observations The object of the study were patients n100 with verified CAD class 2-3 stable angina complicated by CHF NYHA class 2-3 receiving optimal drug therapy
Inclusion Criteria
Age 40-75 years
Verified CAD class 2-3 stable angina complicated by CHF NYHA class 2-3
Signed voluntary informed consent to participate in the study
Non-inclusionexclusion criteria
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 180110mm Hg high pulmonary hypertension grade 2-3 45 mm Hg coagulopathy treatment with anticoagulants with prothrombin time 15 secINR 3 pregnancy aneurysm of the thoracic or abdominal aorta requiring surgical treatment
Refusal of the patient from further participation in the study
6 Specific methods of the planned research
1 Clinical analysis of present symptoms 2 General clinical examination including laboratory research methods general blood count general urinalysis biochemical blood test and instrumental studies electrocardiography echocardiography daily ECG monitoring ultrasound of the vessels of the lower extremities
3 Assessment of exercise tolerance 6-minute walk test 4 Evaluation of the functional status Scale for Assessment of the Clinical State as modified by VYu Mareev
5 Quality of life assessment Questionnaire SF-36 The Short Form-36 MLHFQ Minnesota Living With Heart Failure Questionnaire Minnesota Living With Heart Failure Questionnaire
6 Non-invasive vascular examination assessment of remodeling of the microvasculature computer nailfold capillaroscopy Capillaroscan-1 Russia determination of the structural and functional state of the walls of large vessels and microvasculature photoplethysmography Angioscan-01 Russia determination of the level of central arterial pressure augmentation index applanation tonometry A-pulse CASPro USA
7 The study of patients self-monitoring diaries frequency of angina episodes need for antianginal drugs the frequency of hospitalizations for coronary artery diseaseCHF the frequency of vascular eventsrevascularizations
7 The expected result of the study Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional vascular state exercise tolerance quality of life and prognosis in patients with stable CAD complicated by CHF To substantiate the wider inclusion of treatment with EECP in a comprehensive program for the management of patients with CAD including complicated CHF along with a conservative and invasive strategy to optimize the treatment with EECP in these patients Presentation of the results obtained in the form of publications and implementation of the results in practical healthcare expansion of indications for the treatment of EECP reference to training programs for doctors
8 Base of scientific research Department of Hospital Therapy No 1 First Moscow State Medical University THEM Sechenov University Clinical Hospital No 1 First Moscow State Medical University named after IM Sechenov
9 Calendar terms of performance of work
1 Beginning of material collection December 2020
2 Completion of the collection of material December 2021
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 2483 million cases in 2000 to 4784 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 9275 to 5876 per 100000 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
To study the dynamics of the structural and functional vascular state applanation tonometry photoplethysmography computer nailfold capillaroscopy in active EECP groups 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year initially according to at the end of the course after 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of the clinical status Clinical State Assessment Scale in the groups of active EECP 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year initially at the end of the course after 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of exercise tolerance 6-minute walk test in active EECP groups 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year initially at the end of the course after 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of the quality of life of patients SF36 and MLHFQ questionnaires in the groups of active EECP 220-280 mm Hg 35 procedures 2 courses per year or 1 course per year through the baseline at the end of the course 6 months 1 2 and 3 years and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures at baseline at the end of the course after 6 and 12 months
To study the dynamics of the frequency of angina pectoris episodes the need for antianginal drugs the frequency of vascular events hospitalizations for coronary artery disease CHF deaths in active EECP groups 220-280 mm Hg 35 procedures for 2 or 1 course per year and in the SHAM external counterpulsation group placebo 80 mm Hg 35 procedures during the observation period
To study the effect of EECP on the incidence of primary vascular events hospitalizations for CADCHF deaths and secondary frequency of angina episodes need for antianginal drugs exercise tolerance endpoints
Perform a correlation analysis between EECP treatment parameters number of procedures and duration of treatment with the characteristics under study vascular and clinical effects
4 Planned type of scientific research The study is open prospective randomized controlled in parallel groups
5 Object of study and the planned number of observations The object of the study were patients n100 with verified CAD class 2-3 stable angina complicated by CHF NYHA class 2-3 receiving optimal drug therapy
Inclusion Criteria
Age 40-75 years
Verified CAD class 2-3 stable angina complicated by CHF NYHA class 2-3
Signed voluntary informed consent to participate in the study
Non-inclusionexclusion criteria
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 180110mm Hg high pulmonary hypertension grade 2-3 45 mm Hg coagulopathy treatment with anticoagulants with prothrombin time 15 secINR 3 pregnancy aneurysm of the thoracic or abdominal aorta requiring surgical treatment
Refusal of the patient from further participation in the study
6 Specific methods of the planned research
1 Clinical analysis of present symptoms 2 General clinical examination including laboratory research methods general blood count general urinalysis biochemical blood test and instrumental studies electrocardiography echocardiography daily ECG monitoring ultrasound of the vessels of the lower extremities
3 Assessment of exercise tolerance 6-minute walk test 4 Evaluation of the functional status Scale for Assessment of the Clinical State as modified by VYu Mareev
5 Quality of life assessment Questionnaire SF-36 The Short Form-36 MLHFQ Minnesota Living With Heart Failure Questionnaire Minnesota Living With Heart Failure Questionnaire
6 Non-invasive vascular examination assessment of remodeling of the microvasculature computer nailfold capillaroscopy Capillaroscan-1 Russia determination of the structural and functional state of the walls of large vessels and microvasculature photoplethysmography Angioscan-01 Russia determination of the level of central arterial pressure augmentation index applanation tonometry A-pulse CASPro USA
7 The study of patients self-monitoring diaries frequency of angina episodes need for antianginal drugs the frequency of hospitalizations for coronary artery diseaseCHF the frequency of vascular eventsrevascularizations
7 The expected result of the study Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional vascular state exercise tolerance quality of life and prognosis in patients with stable CAD complicated by CHF To substantiate the wider inclusion of treatment with EECP in a comprehensive program for the management of patients with CAD including complicated CHF along with a conservative and invasive strategy to optimize the treatment with EECP in these patients Presentation of the results obtained in the form of publications and implementation of the results in practical healthcare expansion of indications for the treatment of EECP reference to training programs for doctors
8 Base of scientific research Department of Hospital Therapy No 1 First Moscow State Medical University THEM Sechenov University Clinical Hospital No 1 First Moscow State Medical University named after IM Sechenov
9 Calendar terms of performance of work
1 Beginning of material collection December 2020
2 Completion of the collection of material December 2021
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None