Coronary Artery DiseaseNCT03907293
Effect of a Cardiac Rehabilitation (CR) Programme on Molecular Mechanisms
An observational study of Coronary Artery Disease and Coronary Arteriosclerosis, run by University of Ulster at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Arteriosclerosis, Myocardial Infarction
- What is being tested?
- Exercise-based cardiac rehabilitation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Feb 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Post-myocardial infarction coronary artery disease patients who have been invited to participate in a phase-III cardiac rehabilitation programme with the Belfast Health and Social Care Trust or South Eastern Health and Social Care Trust.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Belfast Health and Social Care Trust (Belfast City Hospital, Mater Hospital, and Royal Victoria Hospital)
Belfast, Co. Antrim, BT9 7AB
South Eastern Health and Social Care Trust (Ulster Hospital)
Dundonald, Co. Down, BT16 1RH
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Myocardial Infarction, Myocardial Ischemia
- Being tested
- Exercise-based cardiac rehabilitation
- Keywords
- Cardiac Rehabilitation, Exercise, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Myocardial Ischemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based cardiac rehabilitationBehavioural
Moderate intensity aerobic exercise, lifestyle advice, and psychological support.
| Study group | Role | What they receive |
|---|---|---|
| Phase-III Cardiac Rehabilitation | Eight weeks of supervised exercise sessions (one session per week). Receives: Behavioral: Exercise-based cardiac rehabilitation | |
| Phase-III and Phase IV Cardiac Rehabilitation | Twenty weeks of supervised exercise sessions (one session per week for first eight weeks [phase-III], session frequency determined by participant for remaining twelve weeks [phase-IV]. Receives: Behavioral: Exercise-based cardiac rehabilitation | |
| No Cardiac Rehabilitation | Participants who declined to take part in a cardiac rehabilitation programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Sirtuin 1 serum protein concentration
Measured in ng/mL
Measured: At baseline and after 22-weeks
Secondary outcomes (20)
Interleukin-6 serum protein concentration
Measured in pg/mL
Measured: Baseline, week-8, and week-22
Interleukin-10 serum protein concentration
Measured in pg/mL
Measured: Baseline, week-8, and week-22
Sirtuin 1 messenger ribonucleic acid gene expression
Measured: Baseline, week-8, and week-22
Interleukin-6 messenger ribonucleic acid gene expression
Measured: Baseline, week-8, and week-22
Interleukin-10 messenger ribonucleic acid gene expression
Measured: Baseline, week-8, and week-22
Erythrocyte sedimentation rate
Millimetres per hour
Measured: Baseline, week-8, and week-22
Serum low-density lipoprotein value
Measured: Baseline, week-8, and week-22
Serum total cholesterol value
Measured: Baseline, week-8, and week-22
Serum triglyceride value
Measured: Baseline, week-8, and week-22
Serum high-density lipoprotein value
Measured: Baseline, week-8, and week-22
Lipid soluble antioxidants concentrations
Measured: Baseline, week-8, and week-22
Lipid hydroperoxide concentration
Measured: Baseline, week-8, and week-22
Ascorbyl free radicle concentration
Measured: Baseline, week-8, and week-22
Brachial flow-mediated dilatation
Percentage increase in arterial diameter
Measured: Baseline, week-8, and week-22
Arterial stiffness (finger photo-plethysmography technique)
Stiffness index
Measured: Baseline, week-8, and week-22
Incremental Shuttle Walk Test
Distance walked (metres)
Measured: Baseline, week-8, and week-22
Systolic and diastolic blood pressure
Millimetre of mercury
Measured: Baseline, week-8, and week-22
Resting heart rate
Beats per minute
Measured: Baseline, week-8, and week-22
Body mass index
Kilograms per metre squared
Measured: Baseline, week-8, and week-22
Waist circumference
Centimetres
Measured: Baseline, week-8, and week-22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start23 Feb 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Ciara Hughes, PhD, Study director, Ulster UniversityGareth Thompson, PhD student, Study chair, Ulster UniversityGareth Davison, PhD, Study chair, Ulster UniversityJacqui Crawford, BSc, MSc, Study chair, Ulster UniversityLisa Spratt, Principal investigator, Belfast Health and Social Care TrustMaureen Morrison, Principal investigator, South Eastern Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907293
- Sponsor's protocol ID
- 18/0056
- Status last verified
- Jan 2021
- First submitted
- 19 Mar 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Thompson G, Wilson IM, Davison GW, Crawford J, Hughes CM. "Why would you not listen? It is like being given the winning lottery numbers and deciding not to take them": semi-structured interviews with post-acute myocardial infarction patients and their significant others exploring factors that influence participation in cardiac rehabilitation and long-term exercise training. Disabil Rehabil. 2022 Aug;44(17):4750-4760. doi: 10.1080/09638288.2021.1919213. Epub 2021 May 7.
PubMed 33961501
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03907293
- Acronym / sponsor ID
- 18/0056
- Conditions
- Coronary Artery Disease, Coronary Arteriosclerosis, Myocardial Infarction, Myocardial Ischemia
- Keywords
- Cardiac Rehabilitation, Exercise, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, South Eastern Health and Social Care Trust
- Study start
- 23 Feb 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase-III Cardiac Rehabilitation | – | Behavioral: Exercise-based cardiac rehabilitationEight weeks of supervised exercise sessions (one session per week). |
| Phase-III and Phase IV Cardiac Rehabilitation | – | Behavioral: Exercise-based cardiac rehabilitationTwenty weeks of supervised exercise sessions (one session per week for first eight weeks [phase-III], session frequency determined by participant for remaining twelve weeks [phase-IV]. |
| No Cardiac Rehabilitation | – | –Participants who declined to take part in a cardiac rehabilitation programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Post-myocardial infarction coronary artery disease patients who have been invited to participate in a phase-III cardiac rehabilitation programme with the Belfast Health and Social Care Trust or South Eastern Health and Social Care Trust.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-based cardiac rehabilitationModerate intensity aerobic exercise, lifestyle advice, and psychological support. | Behavioural | Phase-III Cardiac Rehabilitation, Phase-III and Phase IV Cardiac Rehabilitation |
Primary outcome
Change from baseline Sirtuin 1 serum protein concentration
Time frame: At baseline and after 22-weeks
Measured in ng/mL
20 secondary outcomes
Interleukin-6 serum protein concentration
Time frame: Baseline, week-8, and week-22
Interleukin-10 serum protein concentration
Time frame: Baseline, week-8, and week-22
Sirtuin 1 messenger ribonucleic acid gene expression
Time frame: Baseline, week-8, and week-22
Interleukin-6 messenger ribonucleic acid gene expression
Time frame: Baseline, week-8, and week-22
Interleukin-10 messenger ribonucleic acid gene expression
Time frame: Baseline, week-8, and week-22
Erythrocyte sedimentation rate
Time frame: Baseline, week-8, and week-22
Serum low-density lipoprotein value
Time frame: Baseline, week-8, and week-22
Serum total cholesterol value
Time frame: Baseline, week-8, and week-22
Serum triglyceride value
Time frame: Baseline, week-8, and week-22
Serum high-density lipoprotein value
Time frame: Baseline, week-8, and week-22
Lipid soluble antioxidants concentrations
Time frame: Baseline, week-8, and week-22
Lipid hydroperoxide concentration
Time frame: Baseline, week-8, and week-22
Ascorbyl free radicle concentration
Time frame: Baseline, week-8, and week-22
Brachial flow-mediated dilatation
Time frame: Baseline, week-8, and week-22
Arterial stiffness (finger photo-plethysmography technique)
Time frame: Baseline, week-8, and week-22
Incremental Shuttle Walk Test
Time frame: Baseline, week-8, and week-22
Systolic and diastolic blood pressure
Time frame: Baseline, week-8, and week-22
Resting heart rate
Time frame: Baseline, week-8, and week-22
Body mass index
Time frame: Baseline, week-8, and week-22
Waist circumference
Time frame: Baseline, week-8, and week-22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 33961501Thompson G, Wilson IM, Davison GW, Crawford J, Hughes CM. "Why would you not listen? It is like being given the winning lottery numbers and deciding not to take them": semi-structured interviews with post-acute myocardial infarction patients and their significant others exploring factors that influence participation in cardiac rehabilitation and long-term exercise training. Disabil Rehabil. 2022 Aug;44(17):4750-4760. doi: 10.1080/09638288.2021.1919213. Epub 2021 May 7.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciara Hughes, PhD study director
Ulster University
Gareth Thompson, PhD student study chair
Ulster University
Gareth Davison, PhD study chair
Ulster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Arteriosclerosis, run by University of Ulster at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Sirtuin 1 serum protein concentration (time frame: At baseline and after 22-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.