Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03935438
Status:
RECRUITING
Last Update Posted:
2020-04-29
First Post:
2019-04-26
Brief Title:
The Influence of Cardiac Rehabilitation on the Health State After ACS
Sponsor:
Poznan University of Medical Sciences
Organization:
Poznan University of Medical Sciences
Study Overview
Official Title:
The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2020-04
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:
CARDIO-REH
Brief Summary:
Coronary heart disease including acute coronary syndromes ACS is the leading cause of death in European countries One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation
The aims of the study are evaluation of the impact of cardiac rehabilitation on health state- especially on cardiovascular function parameters in patients after acute coronary syndrome and evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease on the course of cardiac rehabilitation in patients after ACS
The study will consist of a retrospective and prospective part The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation In the retrospective part patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention The prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention
After being included in the study patients will undergo medical examination Then subsequent procedures will be performed anthropometric measurements ECG body composition analysis by bioimpedance measurement of resting blood pressure resting heart rate and oxygen saturation of hemoglobin pulse wave analysis transthoracic echocardiography of the heart 24-hour blood pressure measurement by ambulatory blood pressure monitoring ABPM 24-hour ECG recording using the Holter method electrocardiographic exercise test on a treadmill and or a six-minute walk test or other exercise test adequate to the patients state of health assessment of the quality of the diet assessment of lifestyle acceptance of disease and quality of life assessment of the psychological profile
Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program
After the cardiac rehabilitation program measurement procedures listed above will be repeated
Before and after the cardiac rehabilitation program blood samples urine samples and hair samples will be collected Blood samples urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study
The aims of the study are evaluation of the impact of cardiac rehabilitation on health state- especially on cardiovascular function parameters in patients after acute coronary syndrome and evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease on the course of cardiac rehabilitation in patients after ACS
The study will consist of a retrospective and prospective part The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation In the retrospective part patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention The prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention
After being included in the study patients will undergo medical examination Then subsequent procedures will be performed anthropometric measurements ECG body composition analysis by bioimpedance measurement of resting blood pressure resting heart rate and oxygen saturation of hemoglobin pulse wave analysis transthoracic echocardiography of the heart 24-hour blood pressure measurement by ambulatory blood pressure monitoring ABPM 24-hour ECG recording using the Holter method electrocardiographic exercise test on a treadmill and or a six-minute walk test or other exercise test adequate to the patients state of health assessment of the quality of the diet assessment of lifestyle acceptance of disease and quality of life assessment of the psychological profile
Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program
After the cardiac rehabilitation program measurement procedures listed above will be repeated
Before and after the cardiac rehabilitation program blood samples urine samples and hair samples will be collected Blood samples urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study
Detailed Description:
Coronary heart disease including acute coronary syndromes ACS is the leading cause of death in European countries including Poland In addition it is one of the main causes of disability and the number of lost years of life and the number of years of life lost in good health The costs of its treatment include not only the primary prophylaxis of cardiovascular events the treatment of cardiovascular events the treatment of chronic conditions and complications such as chronic heart failure or arrhythmia but also the secondary and tertiary prophylaxis of acute coronary syndromes
One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation It should be implemented as soon as possible after the ACS and be part of a comprehensive planned and systematic care of the patient after ACS The beneficial effect of cardiac rehabilitation on the cardiovascular system lipid and carbohydrate metabolism and physical performance has been demonstrated in a way that does not raise any doubts However in the light of the growing epidemic of civilization diseases such as excessive body mass diabetes dyslipidemia hypertension and other cardiometabolic disorders it is necessary to conduct high-quality research on the development of the most effective cardiac rehabilitation programs so as to maximize their beneficial effect on patients health
The aims of the study are
1 Evaluation of the impact of cardiac rehabilitation on selected anthropometric biochemical mineral parameters body composition parameters physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome
2 Assessment of lifestyle acceptance of disease quality of life diet and psychological profile and the influence of these factors on the course of cardiac rehabilitation in patients after acute coronary syndrome
3 Evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease and predisposing conditions including excessive body weight hypertension lipid and carbohydrate disorders impaired vascular endothelial function on the course of cardiac rehabilitation in patients after acute coronary syndrome and searching for new genes that may affect the course of cardiac rehabilitation in this group of patients
Research hypotheses
1 Cardiac rehabilitation has a positive effect on selected anthropometric biochemical mineral parameters body composition parameters physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome
2 Lifestyle acceptance of disease quality of life diet and psychological profile have a significant impact on the course of cardiac rehabilitation in patients after acute coronary syndrome
3 The level of expression and gene polymorphism of genes associated with ischemic heart disease and predisposing conditions including excessive body weight hypertension lipid and carbohydrate disorders impaired vascular endothelial function have a significant impact on the course of cardiac rehabilitation in patients after acute coronary syndrome
The study will consist of a retrospective and prospective part The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation In the retrospective part patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention In contrast the prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention
About 200 women and men aged 18 to 99 are planned to be included in the study
After being included in the study patients will undergo medical examination and their medical documentation will be collected analyzed copied and archived Then subsequent procedures will be performed
anthropometric measurements body weight height hip waist neck circumference measurement
ECG - electrocardiography
non-invasive analysis of the body composition by bioimpedance
non-invasive measurement of resting blood pressure resting heart rate and oxygen saturation of hemoglobin
non-invasive pulse wave analysis
non-invasive transthoracic echocardiography of the heart
non-invasive 24-hour blood pressure measurement by ABPM
non-invasive 24-hour ECG recording using the Holter method
non-invasive electrocardiographic exercise test on a treadmill and or a six-minute walk test or other exercise test adequate to the patients state of health these tests will always be preceded by a detailed medical qualification
assessment of the quality of the diet
assessment of lifestyle acceptance of disease and quality of life
assessment of the psychological profile
Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program
After the cardiac rehabilitation program measurement procedures listed above anthropometric measurements ECG non-invasive analysis of the body composition by bioimpedance non-invasive measurement of resting blood pressure resting heart rate and oxygen saturation of hemoglobin non-invasive pulse wave analysis non-invasive transthoracic echocardiography of the heart non-invasive 24-hour blood pressure measurement by ABPM non-invasive 24-hour ECG recording using the Holter method non-invasive electrocardiographic exercise test assessment of the quality of the diet assessment of lifestyle acceptance of disease and quality of life assessment of the psychological profile will be repeated
Before and after the cardiac rehabilitation program blood samples urine samples and hair samples will be collected Blood samples urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study
After data collection statistical analyses will be performed
One of the basic elements of secondary and tertiary prevention of ACS is cardiac rehabilitation It should be implemented as soon as possible after the ACS and be part of a comprehensive planned and systematic care of the patient after ACS The beneficial effect of cardiac rehabilitation on the cardiovascular system lipid and carbohydrate metabolism and physical performance has been demonstrated in a way that does not raise any doubts However in the light of the growing epidemic of civilization diseases such as excessive body mass diabetes dyslipidemia hypertension and other cardiometabolic disorders it is necessary to conduct high-quality research on the development of the most effective cardiac rehabilitation programs so as to maximize their beneficial effect on patients health
The aims of the study are
1 Evaluation of the impact of cardiac rehabilitation on selected anthropometric biochemical mineral parameters body composition parameters physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome
2 Assessment of lifestyle acceptance of disease quality of life diet and psychological profile and the influence of these factors on the course of cardiac rehabilitation in patients after acute coronary syndrome
3 Evaluation of the influence of the level of gene expression and polymorphisms of genes associated with ischemic heart disease and predisposing conditions including excessive body weight hypertension lipid and carbohydrate disorders impaired vascular endothelial function on the course of cardiac rehabilitation in patients after acute coronary syndrome and searching for new genes that may affect the course of cardiac rehabilitation in this group of patients
Research hypotheses
1 Cardiac rehabilitation has a positive effect on selected anthropometric biochemical mineral parameters body composition parameters physical fitness parameters and cardiovascular function parameters in patients after acute coronary syndrome
2 Lifestyle acceptance of disease quality of life diet and psychological profile have a significant impact on the course of cardiac rehabilitation in patients after acute coronary syndrome
3 The level of expression and gene polymorphism of genes associated with ischemic heart disease and predisposing conditions including excessive body weight hypertension lipid and carbohydrate disorders impaired vascular endothelial function have a significant impact on the course of cardiac rehabilitation in patients after acute coronary syndrome
The study will consist of a retrospective and prospective part The retrospective part will include patients who have had acute coronary syndrome in the past and then - before being included in the study - have undergone cardiac rehabilitation In the retrospective part patients enrolled in the study will not undergo cardiac rehabilitation as a part of the study intervention In contrast the prospective part will include patients who have had an acute coronary syndrome in the past and will undergo cardiac rehabilitation as the study intervention
About 200 women and men aged 18 to 99 are planned to be included in the study
After being included in the study patients will undergo medical examination and their medical documentation will be collected analyzed copied and archived Then subsequent procedures will be performed
anthropometric measurements body weight height hip waist neck circumference measurement
ECG - electrocardiography
non-invasive analysis of the body composition by bioimpedance
non-invasive measurement of resting blood pressure resting heart rate and oxygen saturation of hemoglobin
non-invasive pulse wave analysis
non-invasive transthoracic echocardiography of the heart
non-invasive 24-hour blood pressure measurement by ABPM
non-invasive 24-hour ECG recording using the Holter method
non-invasive electrocardiographic exercise test on a treadmill and or a six-minute walk test or other exercise test adequate to the patients state of health these tests will always be preceded by a detailed medical qualification
assessment of the quality of the diet
assessment of lifestyle acceptance of disease and quality of life
assessment of the psychological profile
Subsequently patients taking part in the prospective part of the study will perform a cardiac rehabilitation program
After the cardiac rehabilitation program measurement procedures listed above anthropometric measurements ECG non-invasive analysis of the body composition by bioimpedance non-invasive measurement of resting blood pressure resting heart rate and oxygen saturation of hemoglobin non-invasive pulse wave analysis non-invasive transthoracic echocardiography of the heart non-invasive 24-hour blood pressure measurement by ABPM non-invasive 24-hour ECG recording using the Holter method non-invasive electrocardiographic exercise test assessment of the quality of the diet assessment of lifestyle acceptance of disease and quality of life assessment of the psychological profile will be repeated
Before and after the cardiac rehabilitation program blood samples urine samples and hair samples will be collected Blood samples urine samples and hair samples will also be collected from patients taking part in the retrospective part of the study
After data collection statistical analyses will be performed
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