Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
Study NCT ID:
NCT04268992
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2020-02-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-02', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in cardiorespiratory performance: maximal oxygen uptake', 'timeFrame': '3 months', 'description': 'Changes in maximal oxygen uptake in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group).'}, {'measure': 'Changes in cardiorespiratory performance: maximal power output', 'timeFrame': '3 months', 'description': 'Changes in maximal power output in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group).'}, {'measure': 'Changes in physical health and mental health (quality of life) assessed by the SF-36v2 questionnaire.', 'timeFrame': '3 months', 'description': 'Changes in physical and mental health in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group).'}, {'measure': 'Incidence of adverse events associated with the exercise intervention.', 'timeFrame': '3 months', 'description': 'Number of adverse events (severe, moderate or mild) and training related injuries in coronary artery disease patients who are randomised to long-term exercise.'}], 'primaryOutcomes': [{'measure': 'Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1).', 'timeFrame': '3 months', 'description': 'Changes in fibrinolytic biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare fibrinolytic biomarkers assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in clot maximum absorbance using the clot lysis assay.', 'timeFrame': '3 months', 'description': 'Changes in maximum absorbance in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare clot maximum absorbance assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in clot lysis time using the clot lysis assay.', 'timeFrame': '3 months', 'description': 'Changes in clot lysis time in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare clot lysis time assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in area under the curve using the clot lysis assay.', 'timeFrame': '3 months', 'description': 'Changes in area under the curve in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare area under the curve assessed at baseline and after three months of supervised exercise for every patient.'}], 'secondaryOutcomes': [{'measure': 'Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.', 'timeFrame': '3 months', 'description': 'Changes in platelet aggregation with ASPI as agonist in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.', 'timeFrame': '3 months', 'description': 'Changes in platelet aggregation with ADP as agonist in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.', 'timeFrame': '3 months', 'description': 'Changes in platelet aggregation with TRAP as agonist in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in thrombin generation assessing lag-time until initial thrombin generation.', 'timeFrame': '3 months', 'description': 'Changes in lag-time until initial thrombin generation in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in thrombin generation assessing maximum concentration of thrombin.', 'timeFrame': '3 months', 'description': 'Changes in maximum concentration of thrombin in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in thrombin generation assessing time to peak.', 'timeFrame': '3 months', 'description': 'Changes in time to peak in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in thrombin generation assessing endogenous thrombin potential.', 'timeFrame': '3 months', 'description': 'Changes in endogenous thrombin potential in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare the results assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.', 'timeFrame': '3 months', 'description': 'Changes in coagulation biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare coagulation biomarkers assessed at baseline and after three months of supervised exercise for every patient.'}, {'measure': 'Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.', 'timeFrame': '3 months', 'description': 'Changes in inflammatory biomarkers in coronary artery disease patients who are randomised to long-term exercise compared with patients randomised to usual care (control group). Moreover, the investigators will compare inflammatory biomarkers assessed at baseline and after three months of supervised exercise for every patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular Diseases', 'Exercise', 'Hemostasis', 'Inflammation'], 'conditions': ['Coronary Artery Disease', 'Exercise', 'Inflammation', 'Hemostasis']}, 'referencesModule': {'references': [{'pmid': '37880303', 'type': 'DERIVED', 'citation': 'Sjuretharson T, Kristiansen J, Nordsborg NB, Gregersen NO, Lydersen LN, Grove EL, Kristensen SD, Hvas AM, Mohr M. The angiotensin-converting enzyme I/D polymorphism does not impact training-induced adaptations in exercise capacity in patients with stable coronary artery disease. Sci Rep. 2023 Oct 25;13(1):18300. doi: 10.1038/s41598-023-45542-0.'}, {'pmid': '36428083', 'type': 'DERIVED', 'citation': 'Kristiansen J, Grove EL, Sjuretharson T, Rasmussen J, Mohr M, Kristensen SD, Hvas AM. Haemostasis and fibrinolysis after regular high-intensity interval training in patients with coronary artery disease: a randomised controlled trial. Open Heart. 2022 Nov;9(2):e002127. doi: 10.1136/openhrt-2022-002127.'}, {'pmid': '36241898', 'type': 'DERIVED', 'citation': 'Kristiansen J, Sjuretharson T, Grove EL, Rasmussen J, Kristensen SD, Hvas AM, Mohr M. Feasibility and impact of whole-body high-intensity interval training in patients with stable coronary artery disease: a randomised controlled trial. Sci Rep. 2022 Oct 14;12(1):17295. doi: 10.1038/s41598-022-21655-w.'}]}, 'descriptionModule': {'briefSummary': 'Introduction: Regular exercise training improves prognosis in patients with coronary artery disease (CAD). This study investigates whether the beneficial effects of exercise can be partly explained by favourable changes in haemostasis and inflammation.\n\nMethods: 150 CAD patients are randomised to a supervised long-term exercise program (3 months) or usual care. Blood samples are obtained at baseline, 1.5 months, and 3 months after randomisation.\n\nResults: The investigators will evaluate platelet turnover and aggregation, coagulation, fibrinolysis, and inflammatory markers before and after short- and long-term exercise, and the two randomised groups will be compared.\n\nPerspectives: The present study will increase our knowledge of the beneficial mechanisms underlying the effect of exercise in CAD patients, potentially paving the way for improved exercise recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Angiographically verified coronary artery disease with stenosis of at least 50% or previous percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) surgery.\n* Diagnosis or revascularisation have been made at least 12 months prior to inclusion.\n\nExclusion Criteria:\n\n* Inability to perform strenuous exercise\n* Anticoagulant treatment\n* Heart failure (ejection fraction \\<30% or NYHA \\>2)\n* Implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT)\n* Serious arrhythmia requiring hospitalisation within the last 6 months\n* Severe valvular heart disease\n* Chronic obstructive pulmonary disease GOLD IV'}, 'identificationModule': {'nctId': 'NCT04268992', 'briefTitle': 'Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Aarhus University Hospital'}, 'officialTitle': 'Effect of Long-term Exercise on Haemostasis and Inflammation Compared With Standard Care in Patients With Stable Coronary Artery Disease: a Randomised Clinical Trial', 'orgStudyIdInfo': {'id': '1-16-02-408-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-term exercise', 'description': 'Supervised exercise training three times a week for three months.', 'interventionNames': ['Other: Long-term exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients are not offered supervised exercise.'}], 'interventions': [{'name': 'Long-term exercise', 'type': 'OTHER', 'description': 'All patients randomised to long-term exercise will perform exercise training at least three times a week for three months. The exercise is supervised and individualised.', 'armGroupLabels': ['Long-term exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Tórshavn', 'country': 'Faroe Islands', 'facility': 'National Hospital of the Faroe Islands', 'geoPoint': {'lat': 62.00973, 'lon': -6.77164}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Hospital of the Faroe Islands', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., PhD-student', 'investigatorFullName': 'Jacobina Kristiansen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}