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The Influence of Cardiac Rehabilitation on the Health State After ACS

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03935438
Acronym
CARDIO-REH
Enrollment
200
Registered
2019-05-02
Start date
2019-04-12
Completion date
2024-12-31
Last updated
2020-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Cardiac Rehabilitation

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

OTHERCardiac rehabilitation

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

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Pulse wave velocity (PWV) IAt baselinePulse wave velocity I
PWV IIAfter intervention completion- an average of 2 weeks from baselinePulse wave velocity II

Secondary

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

Countries

Poland

Contacts

Primary ContactDamian Skrypnik, MD; PhD
damian.skrypnik@gmail.com+48798394812
Backup ContactPaweł Bogdański, Prof.
pawelbogdanski73@gmail.com+48502335001

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026