Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease

Overview

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.

Full Title of Study: “Effect of Long-term Exercise on Haemostasis and Inflammation Compared With Standard Care in Patients With Stable Coronary Artery Disease: a Randomised Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2021

Interventions

  • Other: Long-term exercise
    • 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.

Arms, Groups and Cohorts

  • Experimental: Long-term exercise
    • Supervised exercise training three times a week for three months.
  • No Intervention: Usual care
    • Patients are not offered supervised exercise.

Clinical Trial Outcome Measures

Primary Measures

  • 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 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 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 Measures

  • Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.
    • Time Frame: 3 months
    • 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.
  • Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.
    • Time Frame: 3 months
    • 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.
  • Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.
    • Time Frame: 3 months
    • 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.
  • Changes in thrombin generation assessing lag-time until initial thrombin generation.
    • Time Frame: 3 months
    • 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.
  • Changes in thrombin generation assessing maximum concentration of thrombin.
    • Time Frame: 3 months
    • 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.
  • Changes in thrombin generation assessing time to peak.
    • Time Frame: 3 months
    • 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.
  • Changes in thrombin generation assessing endogenous thrombin potential.
    • Time Frame: 3 months
    • 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.
  • Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.
    • Time Frame: 3 months
    • 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.
  • Long-term effects of exercise on inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.
    • Time Frame: 3 months
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aarhus University Hospital
  • Collaborator
    • National Hospital of the Faroe Islands
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jacobina Kristiansen, M.D., PhD-student – Aarhus University Hospital
  • Overall Contact(s)
    • Jacobina Kristiansen, MD, +298 256085, jacobina30@hotmail.com

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