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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268992
Recruitment Status : Not yet recruiting
First Posted : February 13, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
National Hospital of the Faroe Islands
Information provided by (Responsible Party):
Jacobina Kristiansen, Aarhus University Hospital

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Exercise Inflammation Hemostasis Other: Long-term exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Long-term Exercise on Haemostasis and Inflammation Compared With Standard Care in Patients With Stable Coronary Artery Disease: a Randomised Clinical Trial
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Long-term exercise
Supervised exercise training three times a week for three months.
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.

No Intervention: Usual care
Patients are not offered supervised exercise.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268992


Contacts
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Contact: Jacobina Kristiansen, MD +298 256085 jacobina30@hotmail.com

Sponsors and Collaborators
Aarhus University Hospital
National Hospital of the Faroe Islands
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Responsible Party: Jacobina Kristiansen, M.D., PhD-student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04268992    
Other Study ID Numbers: 1-16-02-408-19
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacobina Kristiansen, Aarhus University Hospital:
Cardiovascular Diseases
Exercise
Hemostasis
Inflammation
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases