NCT06418633 Variations in the Hemostatic System Induced by a Standardized Walking Test
| NCT ID | NCT06418633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Venous Thromboembolism |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2025-02-11 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Inclusion criteria common to both groups : * Patients who have given written informed consent. * Patients who are affiliated to or beneficiaries of a social security scheme. Inclusion criteria specific to the Patient Group: * 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. Inclusion criteria specific to the Control Group: * 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 Criteria: * 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.
Contact & Investigator
Antonia PEREZ MARTIN, Prof.
PRINCIPAL INVESTIGATOR
Nîmes University Hospital
Frequently Asked Questions
Who can join the NCT06418633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Venous Thromboembolism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06418633 currently recruiting?
Yes, NCT06418633 is actively recruiting participants. Contact the research team at antonia.perez.martin@chu-nimes.fr for enrollment information.
Where is the NCT06418633 trial being conducted?
This trial is being conducted at Nîmes, France.
Who is sponsoring the NCT06418633 clinical trial?
NCT06418633 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Antonia PEREZ MARTIN, Prof. at Nîmes University Hospital. The trial plans to enroll 94 participants.