Cardiac RehabilitationCARDIO-REHNCT03935438
The Influence of Cardiac Rehabilitation on the Health State After ACS
A study testing Cardiac rehabilitation in people with Cardiac Rehabilitation and Acute Coronary Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation, Acute Coronary Syndrome
- What is being tested?
- Cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 12 Apr 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent in writing
- Coronary heart disease, a state after an acute coronary syndrome
- Female or male
- Age 18 - 99 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
Poznan, Wielkopolska, 60-569
Damian Skrypnik, MD, PhD, +48798394812, damian.skrypnik@gmail.com
Paweł Bogdański, Prof., +48502335001, pawelbogdanski73@gmail.com
About this study
Official title: The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
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.
Read more
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.
Read the 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:
- 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.
- Conditions
- Cardiac Rehabilitation, Acute Coronary Syndrome
- Being tested
- Cardiac rehabilitation
- Keywords
- cardiac rehabilitation, acute coronary syndrome, anthropometric parameters, physical efficiency, cardiovascular function
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients after ACS | Experimental | Patients after acute coronary syndrome undergoing cardiac rehabilitation. Receives: Other: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity (PWV) I
Pulse wave velocity I
Measured: At baseline
PWV II
Pulse wave velocity II
Measured: After intervention completion- an average of 2 weeks from baseline
Secondary outcomes (89)
Aortic pressure (AP) I
Aortic pressure I
Measured: At baseline
AP II
Aortic pressure II
Measured: After intervention completion- an average of 2 weeks from baseline
Body mass (BM) I
Body mass I
Measured: At baseline
BM II
Body mass II
Measured: After intervention completion- an average of 2 weeks from baseline
Body height (BH) I
Body height I
Measured: At baseline
BH II
Body height II
Measured: After intervention completion- an average of 2 weeks from baseline
Body mass index (BMI) I
Body mass index I
Measured: At baseline
BMI II
Body mass index II
Measured: After intervention completion- an average of 2 weeks from baseline
Waist circumference (WC) I
Waist circumference I
Measured: At baseline
WC II
Waist circumference II
Measured: After intervention completion- an average of 2 weeks from baseline
Hip circumference (HC) I
Hip circumference I
Measured: At baseline
HC II
Hip circumference II
Measured: After intervention completion- an average of 2 weeks from baseline
Neck circumference (NC) I
Neck circumference I
Measured: At baseline
NC II
Neck circumference II
Measured: After intervention completion- an average of 2 weeks from baseline
Total fat percentage (TF%) I
Total fat percentage I
Measured: At baseline
TF% II
Total fat percentage II
Measured: After intervention completion- an average of 2 weeks from baseline
Systolic blood pressure (SBP) I
Systolic blood pressure I
Measured: At baseline
SBP II
Systolic blood pressure II
Measured: After intervention completion- an average of 2 weeks from baseline
Diastolic blood pressure (DBP) I
Diastolic blood pressure I
Measured: At baseline
DBP II
Diastolic blood pressure II
Measured: After intervention completion- an average of 2 weeks from baseline
Heart rate (HR) I
Heart rate I
Measured: At baseline
HR II
Heart rate II
Measured: After intervention completion- an average of 2 weeks from baseline
Blood oxygen saturation (SO2) I
Blood oxygen saturation I
Measured: At baseline
SO2 II
Blood oxygen saturation II
Measured: After intervention completion- an average of 2 weeks from baseline
Ejection fraction (EF) I
Ejection fraction I
Measured: At baseline
EF II
Ejection fraction II
Measured: 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
Measured: At baseline
ABPM SBP II
Ambulatory blood pressure monitoring- systolic blood pressure II
Measured: 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
Measured: At baseline
ABPM DBP II
Ambulatory blood pressure monitoring- diastolic blood pressure II
Measured: After intervention completion- an average of 2 weeks from baseline
Metabolic equivalent (MET) I
Metabolic equivalent I
Measured: At baseline
MET II
Metabolic equivalent II
Measured: After intervention completion- an average of 2 weeks from baseline
Distance in 6-minutes walk (6MW-D) I
Distance in 6-minutes walk I
Measured: At baseline
6MW-D II
Distance in 6-minutes walk II
Measured: After intervention completion- an average of 2 weeks from baseline
aspartate aminotransferase (AST) I
Blood concentration of aspartate aminotransferase I
Measured: At baseline
AST II
Blood concentration of aspartate aminotransferase II
Measured: After intervention completion- an average of 2 weeks from baseline
alanine aminotransferase (ALT) I
Blood concentration of alanine aminotransferase I
Measured: At baseline
ALT II
Blood concentration of alanine aminotransferase II
Measured: After intervention completion- an average of 2 weeks from baseline
total bilirubin (TB) I
Blood concentration of total bilirubin I
Measured: At baseline
TB II
Blood concentration of total bilirubin II
Measured: After intervention completion- an average of 2 weeks from baseline
indirect bilirubin (IB) I
Blood concentration of indirect bilirubin I
Measured: At baseline
IB II
Blood concentration of indirect bilirubin II
Measured: After intervention completion- an average of 2 weeks from baseline
direct bilirubin (DB) I
Blood concentration of direct bilirubin I
Measured: At baseline
DB II
Blood concentration of direct bilirubin II
Measured: After intervention completion- an average of 2 weeks from baseline
gamma-glutamyltransferase (GGTP) I
Blood concentration of gamma-glutamyltransferase I
Measured: At baseline
GGTP II
Blood concentration of gamma-glutamyltransferase II
Measured: After intervention completion- an average of 2 weeks from baseline
total cholesterol (TCH) I
Blood concentration of total cholesterol I
Measured: At baseline
TCH II
Blood concentration of total cholesterol II
Measured: After intervention completion- an average of 2 weeks from baseline
low density lipoprotein (LDL) I
Blood concentration of low density lipoprotein I
Measured: At baseline
LDL II
Blood concentration of low density lipoprotein II
Measured: After intervention completion- an average of 2 weeks from baseline
high density lipoprotein (HDL) I
Blood concentration of high density lipoprotein I
Measured: At baseline
HDL II
Blood concentration of high density lipoprotein II
Measured: After intervention completion- an average of 2 weeks from baseline
triglycerides (TG) I
Blood concentration of triglycerides I
Measured: At baseline
TG II
Blood concentration of triglycerides II
Measured: After intervention completion- an average of 2 weeks from baseline
apolipoprotein A (ApoA) I
Blood concentration of apolipoprotein A I
Measured: At baseline
ApoA II
Blood concentration of apolipoprotein A II
Measured: After intervention completion- an average of 2 weeks from baseline
insulin (INS) I
Blood concentration of insulin I
Measured: At baseline
INS II
Blood concentration of insulin II
Measured: After intervention completion- an average of 2 weeks from baseline
glucose (GLU) I
Blood concentration of glucose I
Measured: At baseline
GLU II
Blood concentration of glucose II
Measured: After intervention completion- an average of 2 weeks from baseline
creatinine (CREA) I
Blood concentration of creatinine I
Measured: At baseline
CREA II
Blood concentration of creatinine II
Measured: After intervention completion- an average of 2 weeks from baseline
C-reactive protein (CRP) I
Blood concentration of C-reactive protein I
Measured: At baseline
CRP II
Blood concentration of C-reactive protein II
Measured: After intervention completion- an average of 2 weeks from baseline
adropin (ADR) I
Blood concentration of adropin I
Measured: At baseline
ADR II
Blood concentration of adropin II
Measured: After intervention completion- an average of 2 weeks from baseline
neopterin (NEOPT) I
Blood concentration of neopterin I
Measured: At baseline
NEOPT II
Blood concentration of neopterin II
Measured: 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
Measured: At baseline
NTpro-BNP II
Blood concentration of N-terminal natriuretic propeptide type B II
Measured: After intervention completion- an average of 2 weeks from baseline
magnesium (Mg) I
Blood concentration of magnesium I
Measured: At baseline
Mg II
Blood concentration of magnesium II
Measured: After intervention completion- an average of 2 weeks from baseline
homocysteine (Hcy) I
Blood concentration of homocysteine I
Measured: At baseline
Hcy II
Blood concentration of homocysteine II
Measured: After intervention completion- an average of 2 weeks from baseline
troponin (TROP) I
Blood concentration of troponin I
Measured: At baseline
TROP II
Blood concentration of troponin II
Measured: After intervention completion- an average of 2 weeks from baseline
interleukin 6 (IL6) I
Blood concentration of interleukin 6 I
Measured: At baseline
IL6 II
Blood concentration of interleukin 6 II
Measured: After intervention completion- an average of 2 weeks from baseline
tumor necrosis factor (TNF) I
Blood concentration of tumor necrosis factor I
Measured: At baseline
TNF II
Blood concentration of tumor necrosis factor II
Measured: After intervention completion- an average of 2 weeks from baseline
vascular endothelial growth factor (VEGF) I
Blood concentration of vascular endothelial growth factor I
Measured: At baseline
VEGF II
Blood concentration of vascular endothelial growth factor II
Measured: After intervention completion- an average of 2 weeks from baseline
leptin (LPT) I
Blood concentration of leptin I
Measured: At baseline
LPT II
Blood concentration of leptin II
Measured: After intervention completion- an average of 2 weeks from baseline
VEGF polymorphism
Polymorphism of the VEGF gene
Measured: At baseline
Urine concentration of magnesium (U-Mg) I
Urine concentration of magnesium I
Measured: At baseline
U-Mg II
Urine concentration of magnesium II
Measured: After intervention completion- an average of 2 weeks from baseline
Hair content of magnesium (H-Mg) I
Hair content of magnesium I
Measured: At baseline
H-Mg II
Hair content of magnesium II
Measured: After intervention completion- an average of 2 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start12 Apr 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damian Skrypnik, Poznan University of Medical Sciences
- Investigators
- Damian Skrypnik, MD; PhD, Principal investigator, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935438
- Sponsor's protocol ID
- 476/19
- Acronym
- CARDIO-REH
- Status last verified
- Apr 2020
- First submitted
- 26 Apr 2019
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The decision of individual participant data (IPD) sharing may be changed in the future.
Publications
Skrypnik D, Skrypnik K, Granell JC, Woszczyk D, Suliburska J. Cardiac rehabilitation influences serum myokine levels in patients after acute coronary syndrome: the randomised CARDIO-REH study. Sci Rep. 2025 Nov 6;15(1):38951. doi: 10.1038/s41598-025-22897-0.
PubMed 41198895Skrypnik D, Skrypnik K, Suliburska J, Bogdanski P. Cardiac rehabilitation may influence leptin and VEGF A crosstalk in patients after acute coronary syndrome. Sci Rep. 2022 Jul 12;12(1):11825. doi: 10.1038/s41598-022-16053-1.
PubMed 35821400
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03935438
- Acronym / sponsor ID
- CARDIO-REH / 476/19
- Conditions
- Cardiac Rehabilitation, Acute Coronary Syndrome
- Keywords
- cardiac rehabilitation, acute coronary syndrome, anthropometric parameters, physical efficiency, cardiovascular function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients after ACS | Experimental | Other: Cardiac rehabilitationPatients after acute coronary syndrome undergoing cardiac rehabilitation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent in writing
- Coronary heart disease, a state after an acute coronary syndrome
- Female or male
- Age 18 - 99 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationThe 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. | Other | Patients after ACS |
Primary outcome
Pulse wave velocity (PWV) I
Time frame: At baseline
Pulse wave velocity I
PWV II
Time frame: After intervention completion- an average of 2 weeks from baseline
Pulse wave velocity II
89 secondary outcomes
Aortic pressure (AP) I
Time frame: At baseline
AP II
Time frame: After intervention completion- an average of 2 weeks from baseline
Body mass (BM) I
Time frame: At baseline
BM II
Time frame: After intervention completion- an average of 2 weeks from baseline
Body height (BH) I
Time frame: At baseline
BH II
Time frame: After intervention completion- an average of 2 weeks from baseline
Body mass index (BMI) I
Time frame: At baseline
BMI II
Time frame: After intervention completion- an average of 2 weeks from baseline
Waist circumference (WC) I
Time frame: At baseline
WC II
Time frame: After intervention completion- an average of 2 weeks from baseline
Hip circumference (HC) I
Time frame: At baseline
HC II
Time frame: After intervention completion- an average of 2 weeks from baseline
Neck circumference (NC) I
Time frame: At baseline
NC II
Time frame: After intervention completion- an average of 2 weeks from baseline
Total fat percentage (TF%) I
Time frame: At baseline
TF% II
Time frame: After intervention completion- an average of 2 weeks from baseline
Systolic blood pressure (SBP) I
Time frame: At baseline
SBP II
Time frame: After intervention completion- an average of 2 weeks from baseline
Diastolic blood pressure (DBP) I
Time frame: At baseline
DBP II
Time frame: After intervention completion- an average of 2 weeks from baseline
Heart rate (HR) I
Time frame: At baseline
HR II
Time frame: After intervention completion- an average of 2 weeks from baseline
Blood oxygen saturation (SO2) I
Time frame: At baseline
SO2 II
Time frame: After intervention completion- an average of 2 weeks from baseline
Ejection fraction (EF) I
Time frame: At baseline
EF II
Time frame: After intervention completion- an average of 2 weeks from baseline
Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I
Time frame: At baseline
ABPM SBP II
Time frame: After intervention completion- an average of 2 weeks from baseline
Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I
Time frame: At baseline
ABPM DBP II
Time frame: After intervention completion- an average of 2 weeks from baseline
Metabolic equivalent (MET) I
Time frame: At baseline
MET II
Time frame: After intervention completion- an average of 2 weeks from baseline
Distance in 6-minutes walk (6MW-D) I
Time frame: At baseline
6MW-D II
Time frame: After intervention completion- an average of 2 weeks from baseline
aspartate aminotransferase (AST) I
Time frame: At baseline
AST II
Time frame: After intervention completion- an average of 2 weeks from baseline
alanine aminotransferase (ALT) I
Time frame: At baseline
ALT II
Time frame: After intervention completion- an average of 2 weeks from baseline
total bilirubin (TB) I
Time frame: At baseline
TB II
Time frame: After intervention completion- an average of 2 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 41198895Skrypnik D, Skrypnik K, Granell JC, Woszczyk D, Suliburska J. Cardiac rehabilitation influences serum myokine levels in patients after acute coronary syndrome: the randomised CARDIO-REH study. Sci Rep. 2025 Nov 6;15(1):38951. doi: 10.1038/s41598-025-22897-0.
- Derived from this study: PubMed 35821400Skrypnik D, Skrypnik K, Suliburska J, Bogdanski P. Cardiac rehabilitation may influence leptin and VEGF A crosstalk in patients after acute coronary syndrome. Sci Rep. 2022 Jul 12;12(1):11825. doi: 10.1038/s41598-022-16053-1.
- Individual participant dataSharing planned: No. The decision of individual participant data (IPD) sharing may be changed in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Skrypnik, MD; PhD principal investigator
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation in people with Cardiac Rehabilitation and Acute Coronary Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damian Skrypnik, MD; PhD (+48798394812, damian.skrypnik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (PWV) I (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.