临床试验/NCT06418633

NCT06418633招募中不适用

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 Nīmes1 个研究点分布在 1 个国家目标入组 94 人开始时间: 2025年2月11日最近更新: 2026年6月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 94
试验地点: 1
主要终点: Thrombin generation dosage after effort in controls

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Induced venous thromboembolism is a situation in which venous thromboembolic disease is triggered by an acute event that activates hemostasis: surgery, trauma, infectious or inflammatory outbreak, etc., a situation in which the risk of spontaneous recurrence, in the absence of a new provoking circumstance, is low, leading to the suggestion, not of long-term thromboprophylaxis, but simply the transient prevention of an event when there is a new clinical event likely to activate hemostasis. One such event is acute physical exertion.

Indeed, cohort studies seem to show that regular physical activity is associated with a low incidence of venous thromboembolism. Trained individuals have an endogenous thrombotic potential, assessed by the thrombin TGT test, lower than that of sedentary controls. A 3-month regimen of daily endurance exercise reduces thrombin generation controls and optimizes the fibrinolytic system. Repetitive exercise is accompanied by a depletion of exercise-induced platelet activation. However, several cases of venous thromboembolism have been reported in high-level athletes without usual risk factors and acute high-intensity rowing induces an acute increase in thrombin generation immediately after exercise, which disappears within 16 to 24 hours. The relationship between the level of physical activity and the risk of VTE could be a U-shaped relation, with an increasing risk of event in intense acute practice.

However, no data exists on the hemostatic impact of an acute session of physical activity in patients with a history of venous thromboembolism. Thus, the hypothesis is that exercise-induced response of hemostasis differ in patients with an history of provoked VTE compared to subjects without a history of venous thromboembolism.

This is a proof-of-concept, pathophysiological, single-center, cross-sectional, prospective comparison study of a group of patients with a personal history of induced Venous thromboembolism to a group of sex- and age- and sex-matched controls (+/- 5 years).

- Type of clinical study: Stress test-induced variations in parameters describing the results of the thrombin generation test (Thromboscreen®) in a group of Patients (Cases) will be compared with those obtained in a group of Control subjects (Controls) with a ratio 1:1.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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
•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.

排除标准

•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.

研究组 & 干预措施

Individual reproducibility" subgroup: patients

Active Comparator

10 patients with a history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis, who have accepted to re-do the test one week later.

干预措施: Post-effort blood test (Diagnostic Test)

Individual reproducibility" subgroup: patients

Active Comparator

干预措施: Electrocardiogram (Other)

Control group

Active Comparator

Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives.

干预措施: Electrocardiogram (Other)

Control group

Active Comparator

Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives.

干预措施: 60-minute walking test (Other)

Control group

Active Comparator

Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives.

干预措施: Post-effort blood test (Diagnostic Test)

Control group

Active Comparator

Subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives.

干预措施: Blood pressure monitoring (Other)

Patients

Active Comparator

Patients with a personal history of induced venous thromboembolism, the last attack dating back to more than 6 months, whose clinical phenotype did not justify long-term antithrombotic drug prophylaxis

干预措施: 60-minute walking test (Other)

Patients

Active Comparator

干预措施: Static blood test (Diagnostic Test)

Patients

Active Comparator

干预措施: Post-effort blood test (Diagnostic Test)

Patients

Active Comparator

干预措施: Electrocardiogram (Other)

Patients

Active Comparator

干预措施: Blood pressure monitoring (Other)