Variations in the Hemostatic System Induced by a Standardized Walking Test
Variations in the Hemostatic System Induced by a Standardized Walking Test: Controls Vs. Cases with a History of Non-anticoagulated Venous Thromboembolic Disease
Centre Hospitalier Universitaire de Nīmes
94 participants
Feb 11, 2025
INTERVENTIONAL
Conditions
Summary
Two groups of patients will be compared: One group of patients with a history of venous thromboembolic disease and one group without. Both groups will be subjected to a walking test and with electrocardiogram measurements and blood tests.
Eligibility
Inclusion Criteria17
- Patients who have given written informed consent.
- Patients who are affiliated to or beneficiaries of a social security scheme.
- Patients with a personal history of provoked venous thromboembolism, venous thrombosis and/or pulmonary embolism, with the last attack dating back to more than 6 months, and whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis.
- Definition of provoked venous thromboembolism : The clinical criteria used to classify venous thromboembolism as provoked are :
- First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.
- Hormonal stimulation for oocyte retrieval
- Pregnancy and 6 weeks post-partum
- Surgery
- Trauma
- Immobilisation in plaster or splint
- Outbreak of acute infectious disease
- Acute flare-up of inflammatory disease
- Prolonged air travel lasting at least 4 hours
- Prolonged strict bed rest lasting at least 3 consecutive days.
- Subjects with no personal history of venous thromboembolism
- Subjects with no family history of venous thromboembolism in first-degree relatives
- Subjects of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.
Exclusion Criteria9
- Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise (recent acute coronary syndrome unstable angina, rhythm disorders, tight aortic stenosis, cardiac heart failure, acute myocarditis, pericarditis or endocarditis endocarditis, poorly controlled hypertension, pre-stress blood pressure > 200/110 mmHg, recent stroke or transient ischemic attack).
- Patients on anticoagulant or antithrombotic treatment, ongoing or discontinued within the last month.
- Patients treated for pulmonary embolism who remain dyspneic after anticoagulant treatment and requiring a work-up for pulmonary hypertension.
- Last surgery dating back to less than 3 months.
- Known chronic morbidities: diabetes mellitus, chronic inflammatory or infectious disease, heart failure, renal insufficiency, hepatic insufficiency or arterial thrombosis dating back to less than 3 months.
- For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month
- Pregnancy within the last year.
- Difficult venous access.
- Regular practice of an intensive sporting/physical activity, such as running, tennis, cycling etc. of more than 3 hours per week.
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Interventions
Treadmill walking test in the morning, 2 hours after breakfast, following a clinical examination, resting 12-lead electrocardiogram and blood pressure measurement. After a 3-minute warm-up and walking of speed 2.5 km per hour, no incline, the speed and incline are gradually increased to reach a target heart rate close to the theoretical ventilatory threshold, around 70% of the theoretical maximum value (evaluated by Astrand's formula: 220-age), i.e. aerobic conditions of moderate intensity so that prolonged effort can be maintained. Test performed in presence of a physician trained in stress testing. Emergency cart and defibrillator available in the department. Intra-hospital vital emergency protocol in place, with resuscitation teams on standby. The cardiology department, in the same building, can be contacted in the event of a cardiological abnormality during the test or recovery. The test takes 60 minutes, including a 3-minute initial warm-up.
33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test
33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.
An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.
Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.
Locations(1)
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NCT06418633