The Influence of Cardiac Rehabilitation on the Health State After ACS (CARDIO-REH)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Cardiac Rehabilitation
• Intervention / Treatment: Other: Cardiac rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damian Skrypnik, MD; PhD; Phone Number: +48798394812; Email: damian.skrypnik@gmail.com

Study Locations

• Poland
  • Wielkopolska
    • Poznan, Wielkopolska, Poland, 60-569
      • Recruiting
      • Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients after ACS; Patients after acute coronary syndrome undergoing cardiac rehabilitation.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity (PWV) I	Pulse wave velocity I	At baseline
PWV II	Pulse wave velocity II	After intervention completion- an average of 2 weeks from baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Principal Investigator: Damian Skrypnik, MD; PhD, Poznan University of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: May 1, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: acute coronary syndrome; cardiovascular function; cardiac rehabilitation; anthropometric parameters; physical efficiency
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 476/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The decision of individual participant data (IPD) sharing may be changed in the future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No