Coronary Artery DiseaseNCT04268992
Effect of Long-term Exercise on Haemostasis and Inflammation in Patients With Coronary Artery Disease
A study testing Long-term exercise in people with Coronary Artery Disease and Exercise, run by Aarhus University Hospital at 1 site in Faroe Islands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Exercise, Inflammation
- What is being tested?
- Long-term exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFaroe Islands
- Study dates
- 3 Jul 2020to 16 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Faroe Islands1 site
National Hospital of the Faroe Islands
Tórshavn, 100
About this study
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
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.
Read more
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.
- Conditions
- Coronary Artery Disease, Exercise, Inflammation, Hemostasis
- Being tested
- Long-term exercise
- Keywords
- Cardiovascular Diseases, Exercise, Hemostasis, Inflammation
- Medical subject headings
- Coronary Artery Disease, Motor Activity, Inflammation, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Long-term exercise | Experimental | Supervised exercise training three times a week for three months. Receives: Other: Long-term exercise |
| Usual care | No intervention | Patients are not offered supervised exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1).
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.
Measured: 3 months
Changes in clot maximum absorbance using the clot lysis assay.
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.
Measured: 3 months
Changes in clot lysis time using the clot lysis assay.
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.
Measured: 3 months
Changes in area under the curve using the clot lysis assay.
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.
Measured: 3 months
Secondary outcomes (9)
Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.
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.
Measured: 3 months
Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.
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.
Measured: 3 months
Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.
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.
Measured: 3 months
Changes in thrombin generation assessing lag-time until initial thrombin generation.
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.
Measured: 3 months
Changes in thrombin generation assessing maximum concentration of thrombin.
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.
Measured: 3 months
Changes in thrombin generation assessing time to peak.
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.
Measured: 3 months
Changes in thrombin generation assessing endogenous thrombin potential.
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.
Measured: 3 months
Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.
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.
Measured: 3 months
Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start3 Jul 2020
- Primary completion4 Jun 2021
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Hospital of the Faroe Islands
- Responsible party
- Principal investigator, Jacobina Kristiansen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268992
- Sponsor's protocol ID
- 1-16-02-408-19
- Status last verified
- Aug 2023
- First submitted
- 10 Feb 2020
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kristiansen J, Kristensen SD, Hvas AM, Ellingsgaard H, Mohr M, Grove EL, Sjuretharson T. Effects of Acute Exercise and 12-Week High-Intensity Interval Training on Inflammatory Biomarkers in Stable Coronary Artery Disease: A Randomized Controlled Trial. J Am Heart Assoc. 2026 Feb 17;15(4):e042256. doi: 10.1161/JAHA.125.042256. Epub 2026 Feb 3.
PubMed 41631762Sjuretharson 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.
PubMed 37880303Kristiansen 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.
PubMed 36428083Kristiansen 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.
PubMed 36241898
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04268992
- Acronym / sponsor ID
- 1-16-02-408-19
- Conditions
- Coronary Artery Disease, Exercise, Inflammation, Hemostasis
- Keywords
- Cardiovascular Diseases, Exercise, Hemostasis, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- National Hospital of the Faroe Islands
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Long-term exercise | Experimental | Other: Long-term exerciseSupervised exercise training three times a week for three months. |
| Usual care | No intervention | –Patients are not offered supervised exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term exerciseAll 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. | Other | Long-term exercise |
Primary outcome
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.
9 secondary outcomes
Changes in platelet aggregation using arachidonic acid (ASPI) as agonist.
Time frame: 3 months
Changes in platelet aggregation using adenosine diphosphate (ADP) as agonist.
Time frame: 3 months
Changes in platelet aggregation using thrombin receptor activating peptide-6 (TRAP) as agonist.
Time frame: 3 months
Changes in thrombin generation assessing lag-time until initial thrombin generation.
Time frame: 3 months
Changes in thrombin generation assessing maximum concentration of thrombin.
Time frame: 3 months
Changes in thrombin generation assessing time to peak.
Time frame: 3 months
Changes in thrombin generation assessing endogenous thrombin potential.
Time frame: 3 months
Changes in coagulation biomarkers: APTT, INR, Factor VIII, vWF.
Time frame: 3 months
Changes in inflammatory biomarkers: CRP, multiple interleukins, tumor necrosis factor alpha (TNF-α), interferon gamma (INF-γ) and more.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 41631762Kristiansen J, Kristensen SD, Hvas AM, Ellingsgaard H, Mohr M, Grove EL, Sjuretharson T. Effects of Acute Exercise and 12-Week High-Intensity Interval Training on Inflammatory Biomarkers in Stable Coronary Artery Disease: A Randomized Controlled Trial. J Am Heart Assoc. 2026 Feb 17;15(4):e042256. doi: 10.1161/JAHA.125.042256. Epub 2026 Feb 3.
- Derived from this study: PubMed 37880303Sjuretharson 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.
- Derived from this study: PubMed 36428083Kristiansen 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.
- Derived from this study: PubMed 36241898Kristiansen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term exercise in people with Coronary Artery Disease and Exercise, run by Aarhus University Hospital at 1 site in Faroe Islands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Faroe Islands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fibrinolytic biomarkers: tissue plasminogen activator (t-PA) and plasminogen activator inhibitor-1 (PAI-1). (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268992, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.