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

Primary Purpose

Cardiac Rehabilitation, Acute Coronary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Rehabilitation focused on measuring cardiac rehabilitation, acute coronary syndrome, anthropometric parameters, physical efficiency, cardiovascular function

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients after ACS

Arm Description

Patients after acute coronary syndrome undergoing cardiac rehabilitation.

Outcomes

Primary Outcome Measures

Pulse wave velocity (PWV) I
Pulse wave velocity I
PWV II
Pulse wave velocity II

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2019
Last Updated
April 28, 2020
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03935438
Brief Title
The Influence of Cardiac Rehabilitation on the Health State After ACS
Acronym
CARDIO-REH
Official Title
The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Rehabilitation, Acute Coronary Syndrome
Keywords
cardiac rehabilitation, acute coronary syndrome, anthropometric parameters, physical efficiency, cardiovascular function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Damian Skrypnik, MD; PhD
Phone
+48798394812
Email
damian.skrypnik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Paweł Bogdański, Prof.
Phone
+48502335001
Email
pawelbogdanski73@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Skrypnik, MD; PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences
City
Poznan
State/Province
Wielkopolska
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damian Skrypnik, MD, PhD
Phone
+48798394812
Email
damian.skrypnik@gmail.com
First Name & Middle Initial & Last Name & Degree
Paweł Bogdański, Prof.
Phone
+48502335001
Email
pawelbogdanski73@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The decision of individual participant data (IPD) sharing may be changed in the future.
Citations:
PubMed Identifier
35821400
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.
Results Reference
derived

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The Influence of Cardiac Rehabilitation on the Health State After ACS

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