The Influence of Cardiac Rehabilitation on the Health State After ACS

Acute Coronary Syndrome Clinical Trial

— CARDIO-REH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935438
• Other study ID #: 476/19
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2020
• Source: Poznan University of Medical Sciences
• Contact: Damian Skrypnik, MD; PhD
• Phone: +48798394812
• Email: damian.skrypnik[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Informed consent in writing

• Coronary heart disease, a state after an acute coronary syndrome

• Female or male

• Age 18 - 99 years

Exclusion Criteria:

• Active neoplastic disease

• Alcohol abuse, drug abuse

• Pregnancy, lactation

• Other conditions that in the opinion of researchers may pose any risk to the patient during the study.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiac Rehabilitation
• Syndrome

Intervention

Other:
• Cardiac 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.

Locations

Country	Name	City	State
Poland	Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

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