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Completed

NCT Number: NCT03907293

Effect of a Cardiac Rehabilitation (CR) Programme on Molecular Mechanisms

This study will evaluate the effect of a cardiac rehabilitation (CR) programme on blood protein molecules that may improve the function of arteries in coronary artery disease (CAD) patients who have suffered a heart attack. CAD patients who have either agreed or disagreed to take part in a CR programme will be recruited. This will allow a comparison of the study measurements between a group of patients who complete a CR programme and a group of patients who do not.

The other objective of this study is to perform interviews with the study participants and their significant others (i.e. spouse, family member, or a close friend) to listen to the reasons why patients agreed or disagreed to take part in a CR programme.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Belfast Health and Social Care Trust (Belfast City Hospital, Mater Hospital, and Royal Victoria Hospital), Belfast, Co. Antrim, United Kingdom

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About this study

An exercise-based cardiac rehabilitation (CR) programme is an established method of secondary prevention of coronary artery disease (CAD). Moreover, there is a body of evidence that supports the ability of this intervention to reduce hospital readmissions and cardiovascular mortality. However, despite the proven benefit, CR programmes are underutilised worldwide. Moreover, the molecular mechanisms responsible for orchestrating the beneficial physiological adaptations induced by a CR programme are poorly understood.

Therefore, this study will evaluate the effect of a CR programme on novel molecular mechanisms and endothelial function in post-myocardial infarction CAD patients. Additionally, semi-structured interviews will be conducted with study participants and their significant others (i.e. spouse, family member, or a close friend) to explore the reasons why patients may agree or disagree to take part in a CR programme. Altogether, this study will provide physiological and detailed qualitative information that may help to provoke an increased participation in CR programmes.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Formally diagnosed coronary artery disease with evidence of ST- elevated or non-ST elevated myocardial infarction, as determined by evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia, and the detection of a rise and / or fall in cardiac biomarker values (preferably cardiac troponin), with at least one value above the 99th percentile upper reference limit, along with at least one of the following:

Symptoms of ischaemia, such as: extreme fatigue, breathlessness, chest pain, and heart palpitations.

New or presumed new significant ST-segment-T wave changes or new left bundle branch block.

Development of pathological Q waves on the electrocardiogram.

Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Identification of an intracoronary thrombus by angiography

  • Over 18 years of age.
  • Male or Female.
  • Provision of informed consent.
  • Ability to speak and write in English.
  • Patients who have agreed to participate in a phase-III cardiac rehabilitation programme must be willing to attend the supervised group exercise sessions.
  • No hospital readmissions with unstable symptoms (e.g. chest pain, shortness of breath, discomfort, or nausea) during the previous 4-weeks.
  • Willing to comply with trial requirements.

Exclusion criteria

  • Unstable angina pectoris (angina at rest or persistent angina regardless of pharmacological treatment e.g. glyceryl trinitrate).
  • Uncontrolled cardiac arrhythmia.
  • Survivor of cardiac arrest or cardiogenic shock.
  • Any form of anaemia (haemoglobin < 90 grams / litre).
  • Hepatic failure.
  • Uncontrolled hypertension (resting systolic measurement > 180 mm Hg and / or diastolic measurement > 100 mm Hg).
  • History of Raynaud's phenomenon.
  • Congenital or acquired physical abnormalities of both arms.
  • Consumption of vitamins, herbal, testosterone, estrogen/ progesterone, or antioxidant supplementation.
  • Pregnant.
  • History of or diagnosed with any form of cancer.
  • Current participation in a different research study.

Patient Inclusion Criteria for Interview Component of Study:

  • Patient has either declined or agreed to participate in a phase-III or phase-IV cardiac rehabilitation programme.
  • Sufficient English language skills to understand and participate in an interview discussion.
  • Over 18 years of age.
  • Identified significant other provides informed consent to participate in the study.

Patient Exclusion Criteria for Interview Component of Study:

  • Identified significant other refuses to participate or provide informed consent.

Significant Other Inclusion Criteria for Interview Component of Study:

  • Nominated by the patient and willing to participate.
  • Impacted or involved throughout the period of the patient's cardiovascular complication and recovery (e.g. familial relation, co-habitant, or close-relationship).
  • Sufficient English language skills to understand and participate in an interview discussion.
  • Over 18 years of age.
  • Patient provides informed consent to participate in the study.

Significant Other Exclusion Criteria for Interview Component of Study:

  • Patient refuses to participate or provide informed consent.

Treatment and study plan

Exercise-based Cardiac Rehabilitation

Behavioral

Moderate intensity aerobic exercise, lifestyle advice, and psychological support.

Primary outcomes

  1. Change from baseline Sirtuin 1 serum protein concentration

    Time frame: At baseline and after 22-weeks

    Measured in ng/mL

Secondary outcomes

  1. Interleukin-6 serum protein concentration

    Time frame: Baseline, week-8, and week-22

    Measured in pg/mL

  2. Interleukin-10 serum protein concentration

    Time frame: Baseline, week-8, and week-22

    Measured in pg/mL

  3. Sirtuin 1 messenger ribonucleic acid gene expression

    Time frame: Baseline, week-8, and week-22

  4. Interleukin-6 messenger ribonucleic acid gene expression

    Time frame: Baseline, week-8, and week-22

  5. Interleukin-10 messenger ribonucleic acid gene expression

    Time frame: Baseline, week-8, and week-22

  6. Erythrocyte sedimentation rate

    Time frame: Baseline, week-8, and week-22

    Millimetres per hour

  7. Serum low-density lipoprotein value

    Time frame: Baseline, week-8, and week-22

  8. Serum total cholesterol value

    Time frame: Baseline, week-8, and week-22

  9. Serum triglyceride value

    Time frame: Baseline, week-8, and week-22

  10. Serum high-density lipoprotein value

    Time frame: Baseline, week-8, and week-22

  11. Lipid soluble antioxidants concentrations

    Time frame: Baseline, week-8, and week-22

  12. Lipid hydroperoxide concentration

    Time frame: Baseline, week-8, and week-22

  13. Ascorbyl free radicle concentration

    Time frame: Baseline, week-8, and week-22

  14. Brachial flow-mediated dilatation

    Time frame: Baseline, week-8, and week-22

    Percentage increase in arterial diameter

  15. Arterial stiffness (finger photo-plethysmography technique)

    Time frame: Baseline, week-8, and week-22

    Stiffness index

  16. Incremental Shuttle Walk Test

    Time frame: Baseline, week-8, and week-22

    Distance walked (metres)

  17. Systolic and diastolic blood pressure

    Time frame: Baseline, week-8, and week-22

    Millimetre of mercury

  18. Resting heart rate

    Time frame: Baseline, week-8, and week-22

    Beats per minute

  19. Body mass index

    Time frame: Baseline, week-8, and week-22

    Kilograms per metre squared

  20. Waist circumference

    Time frame: Baseline, week-8, and week-22

    Centimetres

Other outcomes

  1. Qualitative perspectives from study participants and their significant others regarding reasons for agreeing or declining to participate in a phase-III or phase-IV cardiac rehabilitation programme

    Time frame: Week-8 or week-22

    Generated by semi-structured interviews

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Belfast Health and Social Care Trust
  • South Eastern Health and Social Care Trust

Registry information

Official study title

Effect of a Cardiac Rehabilitation (CR) Programme on Protein Molecules Associated With Arterial Function, and an Exploration of Reasons for Agreeing or Declining to Participate in a CR Programme

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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