Effect of Long-term Exercise on Haemostasis and Inflammation Compared With Standard Care in Patients With Stable Coronary Artery Disease: a Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Aarhus University Hospital
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Changes in clot maximum absorbance using the clot lysis assay.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Methods: 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.
Results: 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.
Perspectives: 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.
Investigators
Jacobina Kristiansen
M.D., PhD-student
Aarhus University Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Angiographically verified coronary artery disease with stenosis of at least 50% or previous percutaneous coronary intervention (PCI)/coronary artery bypass graft (CABG) surgery.
- •Diagnosis or revascularisation have been made at least 12 months prior to inclusion.
Exclusion Criteria
- •Inability to perform strenuous exercise
- •Anticoagulant treatment
- •Heart failure (ejection fraction \<30% or NYHA \>2)
- •Implanted implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT)
- •Serious arrhythmia requiring hospitalisation within the last 6 months
- •Severe valvular heart disease
- •Chronic obstructive pulmonary disease GOLD IV
Outcomes
Primary Outcomes
Changes in clot maximum absorbance using the clot lysis assay.
Time Frame: 3 months
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.
Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1).
Time Frame: 3 months
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.
Changes in clot lysis time using the clot lysis assay.
Time Frame: 3 months
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.
Changes in area under the curve using the clot lysis assay.
Time Frame: 3 months
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.
Secondary Outcomes
- Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.(3 months)
- Changes in thrombin generation assessing maximum concentration of thrombin.(3 months)
- Changes in thrombin generation assessing time to peak.(3 months)
- Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.(3 months)
- Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.(3 months)
- Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.(3 months)
- Changes in thrombin generation assessing lag-time until initial thrombin generation.(3 months)
- Changes in thrombin generation assessing endogenous thrombin potential.(3 months)
- Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.(3 months)