Clinical trial NCT03935438: The Influence of Cardiac Rehabilitation on the Health State After ACS
Official title: The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Rehabilitation
Acute Coronary Syndrome
Keywords: cardiac rehabilitation
acute coronary syndrome
anthropometric parameters
physical efficiency
cardiovascular function
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulse wave velocity (PWV) I
timeFrame: At baseline
measure: PWV II
timeFrame: After intervention completion- an average of 2 weeks from baseline
Secondary outcomes:
measure: Aortic pressure (AP) I
timeFrame: At baseline
measure: AP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Body mass (BM) I
timeFrame: At baseline
measure: BM II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Body height (BH) I
timeFrame: At baseline
measure: BH II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Body mass index (BMI) I
timeFrame: At baseline
measure: BMI II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Waist circumference (WC) I
timeFrame: At baseline
measure: WC II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Hip circumference (HC) I
timeFrame: At baseline
measure: HC II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Neck circumference (NC) I
timeFrame: At baseline
measure: NC II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Total fat percentage (TF%) I
timeFrame: At baseline
measure: TF% II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Systolic blood pressure (SBP) I
timeFrame: At baseline
measure: SBP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Diastolic blood pressure (DBP) I
timeFrame: At baseline
measure: DBP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Heart rate (HR) I
timeFrame: At baseline
measure: HR II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Blood oxygen saturation (SO2) I
timeFrame: At baseline
measure: SO2 II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Ejection fraction (EF) I
timeFrame: At baseline
measure: EF II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I
timeFrame: At baseline
measure: ABPM SBP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I
timeFrame: At baseline
measure: ABPM DBP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Metabolic equivalent (MET) I
timeFrame: At baseline
measure: MET II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Distance in 6-minutes walk (6MW-D) I
timeFrame: At baseline
measure: 6MW-D II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: aspartate aminotransferase (AST) I
timeFrame: At baseline
measure: AST II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: alanine aminotransferase (ALT) I
timeFrame: At baseline
measure: ALT II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: total bilirubin (TB) I
timeFrame: At baseline
measure: TB II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: indirect bilirubin (IB) I
timeFrame: At baseline
measure: IB II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: direct bilirubin (DB) I
timeFrame: At baseline
measure: DB II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: gamma-glutamyltransferase (GGTP) I
timeFrame: At baseline
measure: GGTP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: total cholesterol (TCH) I
timeFrame: At baseline
measure: TCH II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: low density lipoprotein (LDL) I
timeFrame: At baseline
measure: LDL II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: high density lipoprotein (HDL) I
timeFrame: At baseline
measure: HDL II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: triglycerides (TG) I
timeFrame: At baseline
measure: TG II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: apolipoprotein A (ApoA) I
timeFrame: At baseline
measure: ApoA II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: insulin (INS) I
timeFrame: At baseline
measure: INS II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: glucose (GLU) I
timeFrame: At baseline
measure: GLU II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: creatinine (CREA) I
timeFrame: At baseline
measure: CREA II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: C-reactive protein (CRP) I
timeFrame: At baseline
measure: CRP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: adropin (ADR) I
timeFrame: At baseline
measure: ADR II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: neopterin (NEOPT) I
timeFrame: At baseline
measure: NEOPT II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: N-terminal natriuretic propeptide type B (NTpro-BNP) I
timeFrame: At baseline
measure: NTpro-BNP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: magnesium (Mg) I
timeFrame: At baseline
measure: Mg II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: homocysteine (Hcy) I
timeFrame: At baseline
measure: Hcy II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: troponin (TROP) I
timeFrame: At baseline
measure: TROP II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: interleukin 6 (IL6) I
timeFrame: At baseline
measure: IL6 II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: tumor necrosis factor (TNF) I
timeFrame: At baseline
measure: TNF II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: vascular endothelial growth factor (VEGF) I
timeFrame: At baseline
measure: VEGF II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: leptin (LPT) I
timeFrame: At baseline
measure: LPT II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: VEGF polymorphism
timeFrame: At baseline
measure: Urine concentration of magnesium (U-Mg) I
timeFrame: At baseline
measure: U-Mg II
timeFrame: After intervention completion- an average of 2 weeks from baseline
measure: Hair content of magnesium (H-Mg) I
timeFrame: At baseline
measure: H-Mg II
timeFrame: After intervention completion- an average of 2 weeks from baseline
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Poznan University of Medical Sciences
name: Damian Skrypnik, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skrypnik 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.