The Influence of Cardiac Rehabilitation on the Health State After ACS
- Conditions
- Cardiac RehabilitationAcute Coronary Syndrome
- Interventions
- Other: Cardiac rehabilitation
- Registration Number
- NCT03935438
- Lead Sponsor
- Poznan University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Informed consent in writing
- Coronary heart disease, a state after an acute coronary syndrome
- Female or male
- Age 18 - 99 years
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients after ACS Cardiac rehabilitation Patients after acute coronary syndrome undergoing cardiac rehabilitation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Waist circumference (WC) I At baseline Waist circumference I
triglycerides (TG) I At baseline Blood concentration of triglycerides I
Aortic pressure (AP) I At baseline Aortic pressure I
BM II After intervention completion- an average of 2 weeks from baseline Body mass II
BH II After intervention completion- an average of 2 weeks from baseline Body height II
AP II After intervention completion- an average of 2 weeks from baseline Aortic pressure II
Body height (BH) I At baseline Body height I
Heart rate (HR) I At baseline Heart rate I
HR II After intervention completion- an average of 2 weeks from baseline Heart rate II
Distance in 6-minutes walk (6MW-D) I At baseline Distance in 6-minutes walk I
alanine aminotransferase (ALT) I At baseline Blood concentration of alanine aminotransferase I
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
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
LDL II After intervention completion- an average of 2 weeks from baseline Blood concentration of low density lipoprotein II
BMI II After intervention completion- an average of 2 weeks from baseline Body mass index II
TB II After intervention completion- an average of 2 weeks from baseline Blood concentration of total bilirubin II
Body mass (BM) I At baseline Body mass I
Body mass index (BMI) I At baseline Body mass index I
Hip circumference (HC) I At baseline Hip circumference I
Blood oxygen saturation (SO2) I At baseline Blood oxygen saturation I
AST II After intervention completion- an average of 2 weeks from baseline Blood concentration of aspartate aminotransferase II
ALT II After intervention completion- an average of 2 weeks from baseline Blood concentration of alanine aminotransferase II
INS II After intervention completion- an average of 2 weeks from baseline Blood concentration of insulin II
GLU II After intervention completion- an average of 2 weeks from baseline Blood concentration of glucose II
HC II After intervention completion- an average of 2 weeks from baseline Hip circumference II
Total fat percentage (TF%) I At baseline Total fat percentage I
SBP II After intervention completion- an average of 2 weeks from baseline Systolic blood pressure II
Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I At baseline Ambulatory blood pressure monitoring- systolic blood pressure I
ABPM DBP II After intervention completion- an average of 2 weeks from baseline Ambulatory blood pressure monitoring- diastolic blood pressure II
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
TG II After intervention completion- an average of 2 weeks from baseline Blood concentration of triglycerides II
creatinine (CREA) I At baseline Blood concentration of creatinine I
CRP II After intervention completion- an average of 2 weeks from baseline Blood concentration of C-reactive protein II
NTpro-BNP II After intervention completion- an average of 2 weeks from baseline Blood concentration of N-terminal natriuretic propeptide type B II
interleukin 6 (IL6) I At baseline Blood concentration of interleukin 6 I
Neck circumference (NC) I At baseline Neck circumference I
WC II After intervention completion- an average of 2 weeks from baseline Waist circumference II
NC II After intervention completion- an average of 2 weeks from baseline Neck circumference II
Systolic blood pressure (SBP) I At baseline Systolic blood pressure 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
ABPM SBP II After intervention completion- an average of 2 weeks from baseline Ambulatory blood pressure monitoring- systolic blood pressure II
Metabolic equivalent (MET) I At baseline Metabolic equivalent I
6MW-D II After intervention completion- an average of 2 weeks from baseline Distance in 6-minutes walk II
aspartate aminotransferase (AST) I At baseline Blood concentration of aspartate aminotransferase I
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
insulin (INS) I At baseline Blood concentration of insulin I
ADR II After intervention completion- an average of 2 weeks from baseline Blood concentration of adropin II
homocysteine (Hcy) I At baseline Blood concentration of homocysteine I
TF% II After intervention completion- an average of 2 weeks from baseline Total fat percentage 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
EF II After intervention completion- an average of 2 weeks from baseline Ejection fraction II
Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I At baseline Ambulatory blood pressure monitoring- diastolic blood pressure I
MET II After intervention completion- an average of 2 weeks from baseline Metabolic equivalent II
total bilirubin (TB) I At baseline Blood concentration of total bilirubin I
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
gamma-glutamyltransferase (GGTP) I At baseline Blood concentration of gamma-glutamyltransferase I
ApoA II After intervention completion- an average of 2 weeks from baseline Blood concentration of apolipoprotein A II
N-terminal natriuretic propeptide type B (NTpro-BNP) I At baseline Blood concentration of N-terminal natriuretic propeptide type B I
magnesium (Mg) I At baseline Blood concentration of magnesium I
TROP II After intervention completion- an average of 2 weeks from baseline Blood concentration of troponin II
TNF II After intervention completion- an average of 2 weeks from baseline Blood concentration of tumor necrosis factor II
apolipoprotein A (ApoA) I At baseline Blood concentration of apolipoprotein A I
glucose (GLU) I At baseline Blood concentration of glucose I
neopterin (NEOPT) I At baseline Blood concentration of neopterin I
Hcy II After intervention completion- an average of 2 weeks from baseline Blood concentration of homocysteine II
VEGF II After intervention completion- an average of 2 weeks from baseline Blood concentration of vascular endothelial growth factor II
VEGF polymorphism At baseline Polymorphism of the VEGF gene
U-Mg II After intervention completion- an average of 2 weeks from baseline Urine concentration of magnesium II
adropin (ADR) I At baseline Blood concentration of adropin I
NEOPT II After intervention completion- an average of 2 weeks from baseline Blood concentration of neopterin II
CREA II After intervention completion- an average of 2 weeks from baseline Blood concentration of creatinine II
C-reactive protein (CRP) I At baseline Blood concentration of C-reactive protein I
Mg II After intervention completion- an average of 2 weeks from baseline Blood concentration of magnesium II
troponin (TROP) I At baseline Blood concentration of troponin I
IL6 II After intervention completion- an average of 2 weeks from baseline Blood concentration of interleukin 6 II
tumor necrosis factor (TNF) I At baseline Blood concentration of tumor necrosis factor I
Urine concentration of magnesium (U-Mg) I At baseline Urine concentration of magnesium I
LPT II After intervention completion- an average of 2 weeks from baseline Blood concentration of leptin II
vascular endothelial growth factor (VEGF) I At baseline Blood concentration of vascular endothelial growth factor I
leptin (LPT) I At baseline Blood concentration of leptin I
H-Mg II After intervention completion- an average of 2 weeks from baseline Hair content of magnesium II
Hair content of magnesium (H-Mg) I At baseline Hair content of magnesium I
Trial Locations
- Locations (1)
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
🇵🇱Poznan, Wielkopolska, Poland