Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-05 @ 6:57 PM
Study NCT ID:
NCT03907293
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2019-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Cardiac Rehabilitation (CR) Programme on Molecular Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum Plasma Whole blood Lymphocytes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2019-03-19', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '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', 'timeFrame': 'Week-8 or week-22', 'description': 'Generated by semi-structured interviews'}], 'primaryOutcomes': [{'measure': 'Change from baseline Sirtuin 1 serum protein concentration', 'timeFrame': 'At baseline and after 22-weeks', 'description': 'Measured in ng/mL'}], 'secondaryOutcomes': [{'measure': 'Interleukin-6 serum protein concentration', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Measured in pg/mL'}, {'measure': 'Interleukin-10 serum protein concentration', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Measured in pg/mL'}, {'measure': 'Sirtuin 1 messenger ribonucleic acid gene expression', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Interleukin-6 messenger ribonucleic acid gene expression', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Interleukin-10 messenger ribonucleic acid gene expression', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Erythrocyte sedimentation rate', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Millimetres per hour'}, {'measure': 'Serum low-density lipoprotein value', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Serum total cholesterol value', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Serum triglyceride value', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Serum high-density lipoprotein value', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Lipid soluble antioxidants concentrations', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Lipid hydroperoxide concentration', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Ascorbyl free radicle concentration', 'timeFrame': 'Baseline, week-8, and week-22'}, {'measure': 'Brachial flow-mediated dilatation', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Percentage increase in arterial diameter'}, {'measure': 'Arterial stiffness (finger photo-plethysmography technique)', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Stiffness index'}, {'measure': 'Incremental Shuttle Walk Test', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Distance walked (metres)'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Millimetre of mercury'}, {'measure': 'Resting heart rate', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Beats per minute'}, {'measure': 'Body mass index', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Kilograms per metre squared'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline, week-8, and week-22', 'description': 'Centimetres'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Rehabilitation', 'Exercise', 'Coronary Artery Disease'], 'conditions': ['Coronary Artery Disease', 'Coronary Arteriosclerosis', 'Myocardial Infarction', 'Myocardial Ischemia']}, 'referencesModule': {'references': [{'pmid': '33961501', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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:\n\nSymptoms of ischaemia, such as: extreme fatigue, breathlessness, chest pain, and heart palpitations.\n\nNew or presumed new significant ST-segment-T wave changes or new left bundle branch block.\n\nDevelopment of pathological Q waves on the electrocardiogram.\n\nImaging evidence of new loss of viable myocardium or new regional wall motion abnormality.\n\nIdentification of an intracoronary thrombus by angiography\n\n* Over 18 years of age.\n* Male or Female.\n* Provision of informed consent.\n* Ability to speak and write in English.\n* Patients who have agreed to participate in a phase-III cardiac rehabilitation programme must be willing to attend the supervised group exercise sessions.\n* No hospital readmissions with unstable symptoms (e.g. chest pain, shortness of breath, discomfort, or nausea) during the previous 4-weeks.\n* Willing to comply with trial requirements.\n\nExclusion Criteria:\n\n* Unstable angina pectoris (angina at rest or persistent angina regardless of pharmacological treatment e.g. glyceryl trinitrate).\n* Uncontrolled cardiac arrhythmia.\n* Survivor of cardiac arrest or cardiogenic shock.\n* Any form of anaemia (haemoglobin \\< 90 grams / litre).\n* Hepatic failure.\n* Uncontrolled hypertension (resting systolic measurement \\> 180 mm Hg and / or diastolic measurement \\> 100 mm Hg).\n* History of Raynaud's phenomenon.\n* Congenital or acquired physical abnormalities of both arms.\n* Consumption of vitamins, herbal, testosterone, estrogen/ progesterone, or antioxidant supplementation.\n* Pregnant.\n* History of or diagnosed with any form of cancer.\n* Current participation in a different research study.\n\nPatient Inclusion Criteria for Interview Component of Study:\n\n* Patient has either declined or agreed to participate in a phase-III or phase-IV cardiac rehabilitation programme.\n* Sufficient English language skills to understand and participate in an interview discussion.\n* Over 18 years of age.\n* Identified significant other provides informed consent to participate in the study.\n\nPatient Exclusion Criteria for Interview Component of Study:\n\n\\- Identified significant other refuses to participate or provide informed consent.\n\nSignificant Other Inclusion Criteria for Interview Component of Study:\n\n* Nominated by the patient and willing to participate.\n* Impacted or involved throughout the period of the patient's cardiovascular complication and recovery (e.g. familial relation, co-habitant, or close-relationship).\n* Sufficient English language skills to understand and participate in an interview discussion.\n* Over 18 years of age.\n* Patient provides informed consent to participate in the study.\n\nSignificant Other Exclusion Criteria for Interview Component of Study:\n\n\\- Patient refuses to participate or provide informed consent."}, 'identificationModule': {'nctId': 'NCT03907293', 'briefTitle': 'Effect of a Cardiac Rehabilitation (CR) Programme on Molecular Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulster'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '18/0056'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phase-III Cardiac Rehabilitation', 'description': 'Eight weeks of supervised exercise sessions (one session per week).', 'interventionNames': ['Behavioral: Exercise-based cardiac rehabilitation']}, {'label': 'Phase-III and Phase IV Cardiac Rehabilitation', 'description': '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\\].', 'interventionNames': ['Behavioral: Exercise-based cardiac rehabilitation']}, {'label': 'No Cardiac Rehabilitation', 'description': 'Participants who declined to take part in a cardiac rehabilitation programme.'}], 'interventions': [{'name': 'Exercise-based cardiac rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Moderate intensity aerobic exercise, lifestyle advice, and psychological support.', 'armGroupLabels': ['Phase-III Cardiac Rehabilitation', 'Phase-III and Phase IV Cardiac Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Co. Antrim', 'country': 'United Kingdom', 'facility': 'Belfast Health and Social Care Trust (Belfast City Hospital, Mater Hospital, and Royal Victoria Hospital)', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'BT16 1RH', 'city': 'Dundonald', 'state': 'Co. Down', 'country': 'United Kingdom', 'facility': 'South Eastern Health and Social Care Trust (Ulster Hospital)', 'geoPoint': {'lat': 54.59196, 'lon': -5.79803}}], 'overallOfficials': [{'name': 'Ciara Hughes, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulster University'}, {'name': 'Gareth Thompson, PhD student', 'role': 'STUDY_CHAIR', 'affiliation': 'Ulster University'}, {'name': 'Gareth Davison, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ulster University'}, {'name': 'Jacqui Crawford, BSc, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Ulster University'}, {'name': 'Lisa Spratt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Belfast Health and Social Care Trust'}, {'name': 'Maureen Morrison', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Eastern Health and Social Care Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulster', 'class': 'OTHER'}, 'collaborators': [{'name': 'Belfast Health and Social Care Trust', 'class': 'OTHER'}, {'name': 'South Eastern Health and Social Care Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}