Acute Coronary Syndrome, Cardiac Rehabilitation
Conditions
Keywords
cardiac rehabilitation, acute coronary syndrome, anthropometric parameters, physical efficiency, cardiovascular function
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 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
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 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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse wave velocity (PWV) I | At baseline | Pulse wave velocity I |
| PWV II | After intervention completion- an average of 2 weeks from baseline | Pulse wave velocity II |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AST II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of aspartate aminotransferase II |
| alanine aminotransferase (ALT) I | At baseline | Blood concentration of alanine aminotransferase I |
| CREA II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of creatinine II |
| Aortic pressure (AP) I | At baseline | Aortic pressure I |
| AP II | After intervention completion- an average of 2 weeks from baseline | Aortic pressure II |
| Body mass (BM) I | At baseline | Body mass I |
| BM II | After intervention completion- an average of 2 weeks from baseline | Body mass II |
| Body height (BH) I | At baseline | Body height I |
| BH II | After intervention completion- an average of 2 weeks from baseline | Body height II |
| Body mass index (BMI) I | At baseline | Body mass index I |
| BMI II | After intervention completion- an average of 2 weeks from baseline | Body mass index II |
| TROP II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of troponin II |
| Waist circumference (WC) I | At baseline | Waist circumference I |
| WC II | After intervention completion- an average of 2 weeks from baseline | Waist circumference II |
| Hip circumference (HC) I | At baseline | Hip circumference I |
| HC II | After intervention completion- an average of 2 weeks from baseline | Hip circumference II |
| Neck circumference (NC) I | At baseline | Neck circumference I |
| NC II | After intervention completion- an average of 2 weeks from baseline | Neck circumference II |
| Total fat percentage (TF%) I | At baseline | Total fat percentage I |
| TF% II | After intervention completion- an average of 2 weeks from baseline | Total fat percentage II |
| Systolic blood pressure (SBP) I | At baseline | Systolic blood pressure I |
| SBP II | After intervention completion- an average of 2 weeks from baseline | Systolic blood pressure II |
| Diastolic blood pressure (DBP) I | At baseline | Diastolic blood pressure I |
| DBP II | After intervention completion- an average of 2 weeks from baseline | Diastolic blood pressure II |
| Heart rate (HR) I | At baseline | Heart rate I |
| interleukin 6 (IL6) I | At baseline | Blood concentration of interleukin 6 I |
| HR II | After intervention completion- an average of 2 weeks from baseline | Heart rate II |
| Blood oxygen saturation (SO2) I | At baseline | Blood oxygen saturation I |
| SO2 II | After intervention completion- an average of 2 weeks from baseline | Blood oxygen saturation II |
| Ejection fraction (EF) I | At baseline | Ejection fraction I |
| EF II | After intervention completion- an average of 2 weeks from baseline | Ejection fraction II |
| Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I | At baseline | Ambulatory blood pressure monitoring- systolic blood pressure I |
| ABPM SBP II | After intervention completion- an average of 2 weeks from baseline | Ambulatory blood pressure monitoring- systolic blood pressure II |
| Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I | At baseline | Ambulatory blood pressure monitoring- diastolic blood pressure I |
| ABPM DBP II | After intervention completion- an average of 2 weeks from baseline | Ambulatory blood pressure monitoring- diastolic blood pressure II |
| Metabolic equivalent (MET) I | At baseline | Metabolic equivalent I |
| MET II | After intervention completion- an average of 2 weeks from baseline | Metabolic equivalent II |
| Distance in 6-minutes walk (6MW-D) I | At baseline | Distance in 6-minutes walk I |
| 6MW-D II | After intervention completion- an average of 2 weeks from baseline | Distance in 6-minutes walk II |
| ALT II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of alanine aminotransferase II |
| total bilirubin (TB) I | At baseline | Blood concentration of total bilirubin I |
| TB II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of total bilirubin II |
| indirect bilirubin (IB) I | At baseline | Blood concentration of indirect bilirubin I |
| IB II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of indirect bilirubin II |
| direct bilirubin (DB) I | At baseline | Blood concentration of direct bilirubin I |
| DB II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of direct bilirubin II |
| gamma-glutamyltransferase (GGTP) I | At baseline | Blood concentration of gamma-glutamyltransferase I |
| GGTP II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of gamma-glutamyltransferase II |
| total cholesterol (TCH) I | At baseline | Blood concentration of total cholesterol I |
| TCH II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of total cholesterol II |
| low density lipoprotein (LDL) I | At baseline | Blood concentration of low density lipoprotein I |
| IL6 II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of interleukin 6 II |
| LDL II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of low density lipoprotein II |
| high density lipoprotein (HDL) I | At baseline | Blood concentration of high density lipoprotein I |
| HDL II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of high density lipoprotein II |
| triglycerides (TG) I | At baseline | Blood concentration of triglycerides I |
| TG II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of triglycerides II |
| apolipoprotein A (ApoA) I | At baseline | Blood concentration of apolipoprotein A I |
| ApoA II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of apolipoprotein A II |
| insulin (INS) I | At baseline | Blood concentration of insulin I |
| INS II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of insulin II |
| glucose (GLU) I | At baseline | Blood concentration of glucose I |
| GLU II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of glucose II |
| C-reactive protein (CRP) I | At baseline | Blood concentration of C-reactive protein I |
| CRP II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of C-reactive protein II |
| adropin (ADR) I | At baseline | Blood concentration of adropin I |
| ADR II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of adropin II |
| neopterin (NEOPT) I | At baseline | Blood concentration of neopterin I |
| NEOPT II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of neopterin II |
| N-terminal natriuretic propeptide type B (NTpro-BNP) I | At baseline | Blood concentration of N-terminal natriuretic propeptide type B I |
| NTpro-BNP II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of N-terminal natriuretic propeptide type B II |
| magnesium (Mg) I | At baseline | Blood concentration of magnesium I |
| Mg II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of magnesium II |
| homocysteine (Hcy) I | At baseline | Blood concentration of homocysteine I |
| Hcy II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of homocysteine II |
| troponin (TROP) I | At baseline | Blood concentration of troponin I |
| tumor necrosis factor (TNF) I | At baseline | Blood concentration of tumor necrosis factor I |
| aspartate aminotransferase (AST) I | At baseline | Blood concentration of aspartate aminotransferase I |
| vascular endothelial growth factor (VEGF) I | At baseline | Blood concentration of vascular endothelial growth factor I |
| VEGF II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of vascular endothelial growth factor II |
| leptin (LPT) I | At baseline | Blood concentration of leptin I |
| LPT II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of leptin II |
| VEGF polymorphism | At baseline | Polymorphism of the VEGF gene |
| Urine concentration of magnesium (U-Mg) I | At baseline | Urine concentration of magnesium I |
| U-Mg II | After intervention completion- an average of 2 weeks from baseline | Urine concentration of magnesium II |
| Hair content of magnesium (H-Mg) I | At baseline | Hair content of magnesium I |
| H-Mg II | After intervention completion- an average of 2 weeks from baseline | Hair content of magnesium II |
| TNF II | After intervention completion- an average of 2 weeks from baseline | Blood concentration of tumor necrosis factor II |
| creatinine (CREA) I | At baseline | Blood concentration of creatinine I |
Countries
Poland