The Influence of Cardiac Rehabilitation on the Health State After ACS

Study Overview
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Brief Summary
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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 patient's 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
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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: 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. 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. 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: 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. 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. 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 patient's 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.

Official Title
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The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome

Conditions
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Cardiac Rehabilitation, Acute Coronary Syndrome

Intervention / Treatment
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* Other: Cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent in writing Coronary heart disease, a state after an acute coronary syndrome Female or male Age 18 - 99 years Exclusion Criteria: Active neoplastic disease Alcohol abuse, drug abuse Pregnancy, lactation Other conditions that in the opinion of researchers may pose any risk to the patient during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients after ACS<br>Patients after acute coronary syndrome undergoing cardiac rehabilitation. | Other: Cardiac rehabilitation<br>* The training program of cardiac rehabilitation, depending on the results of the patient's medical qualification, will consist of the following: free active exercises, isometric exercises, active exercises in relief with resistance, isotonic exercises, isokinetic exercises, active breathing exercises, active breathing exercises with resistance, balance exercises, general exercises- individual and in groups, interval training on a treadmill or cycling cycloergometer, continuous training on a treadmill or cycling cycloergometer, circuit training, walking training, march training with accessories, autogenic training, walking. The training program will last an average 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity (PWV) I | Pulse wave velocity I | At baseline | 
| PWV II | Pulse wave velocity II | After intervention completion- an average of 2 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic pressure (AP) I | Aortic pressure I | At baseline | 
| AP II | Aortic pressure II | After intervention completion- an average of 2 weeks from baseline | 
| Body mass (BM) I | Body mass I | At baseline | 
| BM II | Body mass II | After intervention completion- an average of 2 weeks from baseline | 
| Body height (BH) I | Body height I | At baseline | 
| BH II | Body height II | After intervention completion- an average of 2 weeks from baseline | 
| Body mass index (BMI) I | Body mass index I | At baseline | 
| BMI II | Body mass index II | After intervention completion- an average of 2 weeks from baseline | 
| Waist circumference (WC) I | Waist circumference I | At baseline | 
| WC II | Waist circumference II | After intervention completion- an average of 2 weeks from baseline | 
| Hip circumference (HC) I | Hip circumference I | At baseline | 
| HC II | Hip circumference II | After intervention completion- an average of 2 weeks from baseline | 
| Neck circumference (NC) I | Neck circumference I | At baseline | 
| NC II | Neck circumference II | After intervention completion- an average of 2 weeks from baseline | 
| Total fat percentage (TF%) I | Total fat percentage I | At baseline | 
| TF% II | Total fat percentage II | After intervention completion- an average of 2 weeks from baseline | 
| Systolic blood pressure (SBP) I | Systolic blood pressure I | At baseline | 
| SBP II | Systolic blood pressure II | After intervention completion- an average of 2 weeks from baseline | 
| Diastolic blood pressure (DBP) I | Diastolic blood pressure I | At baseline | 
| DBP II | Diastolic blood pressure II | After intervention completion- an average of 2 weeks from baseline | 
| Heart rate (HR) I | Heart rate I | At baseline | 
| HR II | Heart rate II | After intervention completion- an average of 2 weeks from baseline | 
| Blood oxygen saturation (SO2) I | Blood oxygen saturation I | At baseline | 
| SO2 II | Blood oxygen saturation II | After intervention completion- an average of 2 weeks from baseline | 
| Ejection fraction (EF) I | Ejection fraction I | At baseline | 
| EF II | Ejection fraction II | After intervention completion- an average of 2 weeks from baseline | 
| Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I | Ambulatory blood pressure monitoring- systolic blood pressure I | At baseline | 
| ABPM SBP II | Ambulatory blood pressure monitoring- systolic blood pressure II | After intervention completion- an average of 2 weeks from baseline | 
| Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I | Ambulatory blood pressure monitoring- diastolic blood pressure I | At baseline | 
| ABPM DBP II | Ambulatory blood pressure monitoring- diastolic blood pressure II | After intervention completion- an average of 2 weeks from baseline | 
| Metabolic equivalent (MET) I | Metabolic equivalent I | At baseline | 
| MET II | Metabolic equivalent II | After intervention completion- an average of 2 weeks from baseline | 
| Distance in 6-minutes walk (6MW-D) I | Distance in 6-minutes walk I | At baseline | 
| 6MW-D II | Distance in 6-minutes walk II | After intervention completion- an average of 2 weeks from baseline | 
| aspartate aminotransferase (AST) I | Blood concentration of aspartate aminotransferase I | At baseline | 
| AST II | Blood concentration of aspartate aminotransferase II | After intervention completion- an average of 2 weeks from baseline | 
| alanine aminotransferase (ALT) I | Blood concentration of alanine aminotransferase I | At baseline | 
| ALT II | Blood concentration of alanine aminotransferase II | After intervention completion- an average of 2 weeks from baseline | 
| total bilirubin (TB) I | Blood concentration of total bilirubin I | At baseline | 
| TB II | Blood concentration of total bilirubin II | After intervention completion- an average of 2 weeks from baseline | 
| indirect bilirubin (IB) I | Blood concentration of indirect bilirubin I | At baseline | 
| IB II | Blood concentration of indirect bilirubin II | After intervention completion- an average of 2 weeks from baseline | 
| direct bilirubin (DB) I | Blood concentration of direct bilirubin I | At baseline | 
| DB II | Blood concentration of direct bilirubin II | After intervention completion- an average of 2 weeks from baseline | 
| gamma-glutamyltransferase (GGTP) I | Blood concentration of gamma-glutamyltransferase I | At baseline | 
| GGTP II | Blood concentration of gamma-glutamyltransferase II | After intervention completion- an average of 2 weeks from baseline | 
| total cholesterol (TCH) I | Blood concentration of total cholesterol I | At baseline | 
| TCH II | Blood concentration of total cholesterol II | After intervention completion- an average of 2 weeks from baseline | 
| low density lipoprotein (LDL) I | Blood concentration of low density lipoprotein I | At baseline | 
| LDL II | Blood concentration of low density lipoprotein II | After intervention completion- an average of 2 weeks from baseline | 
| high density lipoprotein (HDL) I | Blood concentration of high density lipoprotein I | At baseline | 
| HDL II | Blood concentration of high density lipoprotein II | After intervention completion- an average of 2 weeks from baseline | 
| triglycerides (TG) I | Blood concentration of triglycerides I | At baseline | 
| TG II | Blood concentration of triglycerides II | After intervention completion- an average of 2 weeks from baseline | 
| apolipoprotein A (ApoA) I | Blood concentration of apolipoprotein A I | At baseline | 
| ApoA II | Blood concentration of apolipoprotein A II | After intervention completion- an average of 2 weeks from baseline | 
| insulin (INS) I | Blood concentration of insulin I | At baseline | 
| INS II | Blood concentration of insulin II | After intervention completion- an average of 2 weeks from baseline | 
| glucose (GLU) I | Blood concentration of glucose I | At baseline | 
| GLU II | Blood concentration of glucose II | After intervention completion- an average of 2 weeks from baseline | 
| creatinine (CREA) I | Blood concentration of creatinine I | At baseline | 
| CREA II | Blood concentration of creatinine II | After intervention completion- an average of 2 weeks from baseline | 
| C-reactive protein (CRP) I | Blood concentration of C-reactive protein I | At baseline | 
| CRP II | Blood concentration of C-reactive protein II | After intervention completion- an average of 2 weeks from baseline | 
| adropin (ADR) I | Blood concentration of adropin I | At baseline | 
| ADR II | Blood concentration of adropin II | After intervention completion- an average of 2 weeks from baseline | 
| neopterin (NEOPT) I | Blood concentration of neopterin I | At baseline | 
| NEOPT II | Blood concentration of neopterin II | After intervention completion- an average of 2 weeks from baseline | 
| N-terminal natriuretic propeptide type B (NTpro-BNP) I | Blood concentration of N-terminal natriuretic propeptide type B I | At baseline | 
| NTpro-BNP II | Blood concentration of N-terminal natriuretic propeptide type B II | After intervention completion- an average of 2 weeks from baseline | 
| magnesium (Mg) I | Blood concentration of magnesium I | At baseline | 
| Mg II | Blood concentration of magnesium II | After intervention completion- an average of 2 weeks from baseline | 
| homocysteine (Hcy) I | Blood concentration of homocysteine I | At baseline | 
| Hcy II | Blood concentration of homocysteine II | After intervention completion- an average of 2 weeks from baseline | 
| troponin (TROP) I | Blood concentration of troponin I | At baseline | 
| TROP II | Blood concentration of troponin II | After intervention completion- an average of 2 weeks from baseline | 
| interleukin 6 (IL6) I | Blood concentration of interleukin 6 I | At baseline | 
| IL6 II | Blood concentration of interleukin 6 II | After intervention completion- an average of 2 weeks from baseline | 
| tumor necrosis factor (TNF) I | Blood concentration of tumor necrosis factor I | At baseline | 
| TNF II | Blood concentration of tumor necrosis factor II | After intervention completion- an average of 2 weeks from baseline | 
| vascular endothelial growth factor (VEGF) I | Blood concentration of vascular endothelial growth factor I | At baseline | 
| VEGF II | Blood concentration of vascular endothelial growth factor II | After intervention completion- an average of 2 weeks from baseline | 
| leptin (LPT) I | Blood concentration of leptin I | At baseline | 
| LPT II | Blood concentration of leptin II | After intervention completion- an average of 2 weeks from baseline | 
| VEGF polymorphism | Polymorphism of the VEGF gene | At baseline | 
| Urine concentration of magnesium (U-Mg) I | Urine concentration of magnesium I | At baseline | 
| U-Mg II | Urine concentration of magnesium II | After intervention completion- an average of 2 weeks from baseline | 
| Hair content of magnesium (H-Mg) I | Hair content of magnesium I | At baseline | 
| H-Mg II | Hair content of magnesium II | After intervention completion- an average of 2 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, acute coronary syndrome, anthropometric parameters, physical efficiency, cardiovascular function