New treatment option for Venous Thromboembolism
Official title Variations in the Hemostatic System Induced by a Standardized Walking Test
ClinicalTrials.gov ID: NCT06418633
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- common to both groups :
- Patients who have given written informed consent.
- Patients who are affiliated to or beneficiaries of a social security scheme. 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...
- First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous...
You likely can't join if
- Patients who are physically unable to perform the 60-minute walking test, for any reason, in particular cardiovascular contraindications to exercise...
- 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...
- For women: treatment containing synthetic or natural estrogen, in progress or discontinued for less than a month
See the full eligibility criteria
- common to both groups :
- Patients who have given written informed consent.
- Patients who are affiliated to or beneficiaries of a social security scheme. 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...
- 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. specific to the Control Group:
- people with no personal history of venous thromboembolism
- people with no family history of venous thromboembolism in first-degree relatives
- people of the same sex and age with a tolerance of +/- 5 years in relation to the matched case.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nîmes, Occitanie, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nîmes, Occitanie, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.