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Trial record 10 of 11 for:    ANXA2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03935438
Recruitment Status : Not yet recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Damian Skrypnik, Poznan University of Medical Sciences

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935438


Contacts
Layout table for location contacts
Contact: Damian Skrypnik, MD; PhD +48798394812 damian.skrypnik@gmail.com
Contact: Paweł Bogdański, Prof. +48502335001 pawelbogdanski73@gmail.com

Locations
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Poland
Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences Not yet 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
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Principal Investigator: Damian Skrypnik, MD; PhD Poznan University of Medical Sciences

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

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