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

• ClinicalTrials.gov Identifier: NCT03935438
• Recruitment Status: Recruiting
• First Posted: May 2, 2019
• Last Update Posted: April 29, 2020
• Sponsor: Poznan University of Medical Sciences
• Information provided by (Responsible Party): Damian Skrypnik, Poznan University of Medical Sciences

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Rehabilitation; Acute Coronary Syndrome	Other: Cardiac rehabilitation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Influence of Cardiac Rehabilitation on the Health State of Patients After Acute Coronary Syndrome
• Actual Study Start Date: April 12, 2019
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Pulse wave velocity (PWV) I [ Time Frame: At baseline ]
   Pulse wave velocity I
2. PWV II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
   Pulse wave velocity II

Secondary Outcome Measures :

1. Aortic pressure (AP) I [ Time Frame: At baseline ]
   Aortic pressure I
2. AP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
   Aortic pressure II
3. Body mass (BM) I [ Time Frame: At baseline ]
   Body mass I
4. BM II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
   Body mass II
5. Body height (BH) I [ Time Frame: At baseline ]
   Body height I
6. BH II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
   Body height II
7. Body mass index (BMI) I [ Time Frame: At baseline ]
   Body mass index I
8. BMI II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
   Body mass index II
9. Waist circumference (WC) I [ Time Frame: At baseline ]
   Waist circumference I
10. WC II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Waist circumference II
11. Hip circumference (HC) I [ Time Frame: At baseline ]
    Hip circumference I
12. HC II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Hip circumference II
13. Neck circumference (NC) I [ Time Frame: At baseline ]
    Neck circumference I
14. NC II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Neck circumference II
15. Total fat percentage (TF%) I [ Time Frame: At baseline ]
    Total fat percentage I
16. TF% II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Total fat percentage II
17. Systolic blood pressure (SBP) I [ Time Frame: At baseline ]
    Systolic blood pressure I
18. SBP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Systolic blood pressure II
19. Diastolic blood pressure (DBP) I [ Time Frame: At baseline ]
    Diastolic blood pressure I
20. DBP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Diastolic blood pressure II
21. Heart rate (HR) I [ Time Frame: At baseline ]
    Heart rate I
22. HR II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Heart rate II
23. Blood oxygen saturation (SO2) I [ Time Frame: At baseline ]
    Blood oxygen saturation I
24. SO2 II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood oxygen saturation II
25. Ejection fraction (EF) I [ Time Frame: At baseline ]
    Ejection fraction I
26. EF II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Ejection fraction II
27. Ambulatory blood pressure monitoring- systolic blood pressure (ABPM SBP) I [ Time Frame: At baseline ]
    Ambulatory blood pressure monitoring- systolic blood pressure I
28. ABPM SBP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Ambulatory blood pressure monitoring- systolic blood pressure II
29. Ambulatory blood pressure monitoring- diastolic blood pressure (ABPM DBP) I [ Time Frame: At baseline ]
    Ambulatory blood pressure monitoring- diastolic blood pressure I
30. ABPM DBP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Ambulatory blood pressure monitoring- diastolic blood pressure II
31. Metabolic equivalent (MET) I [ Time Frame: At baseline ]
    Metabolic equivalent I
32. MET II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Metabolic equivalent II
33. Distance in 6-minutes walk (6MW-D) I [ Time Frame: At baseline ]
    Distance in 6-minutes walk I
34. 6MW-D II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Distance in 6-minutes walk II
35. aspartate aminotransferase (AST) I [ Time Frame: At baseline ]
    Blood concentration of aspartate aminotransferase I
36. AST II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of aspartate aminotransferase II
37. alanine aminotransferase (ALT) I [ Time Frame: At baseline ]
    Blood concentration of alanine aminotransferase I
38. ALT II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of alanine aminotransferase II
39. total bilirubin (TB) I [ Time Frame: At baseline ]
    Blood concentration of total bilirubin I
40. TB II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of total bilirubin II
41. indirect bilirubin (IB) I [ Time Frame: At baseline ]
    Blood concentration of indirect bilirubin I
42. IB II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of indirect bilirubin II
43. direct bilirubin (DB) I [ Time Frame: At baseline ]
    Blood concentration of direct bilirubin I
44. DB II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of direct bilirubin II
45. gamma-glutamyltransferase (GGTP) I [ Time Frame: At baseline ]
    Blood concentration of gamma-glutamyltransferase I
46. GGTP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of gamma-glutamyltransferase II
47. total cholesterol (TCH) I [ Time Frame: At baseline ]
    Blood concentration of total cholesterol I
48. TCH II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of total cholesterol II
49. low density lipoprotein (LDL) I [ Time Frame: At baseline ]
    Blood concentration of low density lipoprotein I
50. LDL II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of low density lipoprotein II
51. high density lipoprotein (HDL) I [ Time Frame: At baseline ]
    Blood concentration of high density lipoprotein I
52. HDL II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of high density lipoprotein II
53. triglycerides (TG) I [ Time Frame: At baseline ]
    Blood concentration of triglycerides I
54. TG II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of triglycerides II
55. apolipoprotein A (ApoA) I [ Time Frame: At baseline ]
    Blood concentration of apolipoprotein A I
56. ApoA II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of apolipoprotein A II
57. insulin (INS) I [ Time Frame: At baseline ]
    Blood concentration of insulin I
58. INS II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of insulin II
59. glucose (GLU) I [ Time Frame: At baseline ]
    Blood concentration of glucose I
60. GLU II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of glucose II
61. creatinine (CREA) I [ Time Frame: At baseline ]
    Blood concentration of creatinine I
62. CREA II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of creatinine II
63. C-reactive protein (CRP) I [ Time Frame: At baseline ]
    Blood concentration of C-reactive protein I
64. CRP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of C-reactive protein II
65. adropin (ADR) I [ Time Frame: At baseline ]
    Blood concentration of adropin I
66. ADR II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of adropin II
67. neopterin (NEOPT) I [ Time Frame: At baseline ]
    Blood concentration of neopterin I
68. NEOPT II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of neopterin II
69. N-terminal natriuretic propeptide type B (NTpro-BNP) I [ Time Frame: At baseline ]
    Blood concentration of N-terminal natriuretic propeptide type B I
70. NTpro-BNP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of N-terminal natriuretic propeptide type B II
71. magnesium (Mg) I [ Time Frame: At baseline ]
    Blood concentration of magnesium I
72. Mg II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of magnesium II
73. homocysteine (Hcy) I [ Time Frame: At baseline ]
    Blood concentration of homocysteine I
74. Hcy II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of homocysteine II
75. troponin (TROP) I [ Time Frame: At baseline ]
    Blood concentration of troponin I
76. TROP II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of troponin II
77. interleukin 6 (IL6) I [ Time Frame: At baseline ]
    Blood concentration of interleukin 6 I
78. IL6 II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of interleukin 6 II
79. tumor necrosis factor (TNF) I [ Time Frame: At baseline ]
    Blood concentration of tumor necrosis factor I
80. TNF II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of tumor necrosis factor II
81. vascular endothelial growth factor (VEGF) I [ Time Frame: At baseline ]
    Blood concentration of vascular endothelial growth factor I
82. VEGF II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of vascular endothelial growth factor II
83. leptin (LPT) I [ Time Frame: At baseline ]
    Blood concentration of leptin I
84. LPT II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Blood concentration of leptin II
85. VEGF polymorphism [ Time Frame: At baseline ]
    Polymorphism of the VEGF gene
86. Urine concentration of magnesium (U-Mg) I [ Time Frame: At baseline ]
    Urine concentration of magnesium I
87. U-Mg II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Urine concentration of magnesium II
88. Hair content of magnesium (H-Mg) I [ Time Frame: At baseline ]
    Hair content of magnesium I
89. H-Mg II [ Time Frame: After intervention completion- an average of 2 weeks from baseline ]
    Hair content of magnesium II

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Damian Skrypnik, MD; PhD; +48798394812; damian.skrypnik@gmail.com

Contact: Paweł Bogdański, Prof.; +48502335001; pawelbogdanski73@gmail.com

Locations

Poland

Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences; Recruiting

Poznan, Wielkopolska, Poland, 60-569

Contact: Damian Skrypnik, MD, PhD +48798394812 damian.skrypnik@gmail.com

Contact: Paweł Bogdański, Prof. +48502335001 pawelbogdanski73@gmail.com

Sponsors and Collaborators

Poznan University of Medical Sciences

Investigators

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

More Information

• Responsible Party: Damian Skrypnik, Principal Investigator and Study Manager; Doctor of Medicine, Poznan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03935438
• Other Study ID Numbers: 476/19
• First Posted: May 2, 2019
• Last Update Posted: April 29, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The decision of individual participant data (IPD) sharing may be changed in the future.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Damian Skrypnik, Poznan University of Medical Sciences:

cardiac rehabilitation; acute coronary syndrome; anthropometric parameters; physical efficiency; cardiovascular function

Additional relevant MeSH terms:

Acute Coronary Syndrome; Syndrome; Disease; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases