NCT06418633

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Feb 2025Apr 2027

First Submitted

Initial submission to the registry

April 28, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

February 11, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

April 28, 2024

Last Update Submit

February 17, 2025

Conditions

Venous Thromboembolism

Keywords

Physical exercise

Outcome Measures

Primary Outcomes (8)

  • Thrombin generation dosage before effort in controls

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

    Day 0

  • Thrombin generation dosage before effort in patients

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

    Day 0

  • Thrombin generation dosage after effort in controls

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

    Day 0

  • Thrombin generation dosage after effort in patients

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

    Day 0

  • Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: controls

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

    Day 7

  • Thrombin generation dosage before effort in the "Individual reproducibility" subgroup: patients

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM)

    Day 7

  • Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: controls

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

    Day 7

  • Thrombin generation dosage after effort in the "Individual reproducibility" subgroup: patients

    The amount of thrombomodulin in the blood will be measured in nmol/L with the help of Thromboscreen(TM). The difference between measurements before and after effort will be measured in nM.min-1

    Day 7

Secondary Outcomes (230)

  • Distribution in the Control group

    Day 0

  • Distribution in the Patient group

    Day 0

  • Thromboscreen test in Controls in the absence of thrombomodulin : Latency time

    Day 0

  • Thromboscreen test in Controls in the absence of thrombomodulin : Thrombin peak intensity

    Day 0

  • Thromboscreen test in Controls in the absence of thrombomodulin : Time-to-peak thrombin

    Day 0

  • +225 more secondary outcomes

Other Outcomes (6)

  • Age in Controls

    Day 0

  • Sex in Controls

    Day 0

  • Body mass index in Controls

    Day 0

  • +3 more other outcomes

Study Arms (4)

Control group

ACTIVE COMPARATOR

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

Other: 60-minute walking testDiagnostic Test: Static blood testDiagnostic Test: Post-effort blood testOther: ElectrocardiogramOther: Blood pressure monitoring

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

Other: 60-minute walking testDiagnostic Test: Static blood testDiagnostic Test: Post-effort blood testOther: ElectrocardiogramOther: Blood pressure monitoring

Individual reproducibility" subgroup: controls

ACTIVE COMPARATOR

10 subjects with neither a personal history nor family history of venous thromboembolism in first-degree relatives who have accepted to re-do the test one week later.

Other: 60-minute walking testDiagnostic Test: Static blood testDiagnostic Test: Post-effort blood testOther: ElectrocardiogramOther: Blood pressure monitoring

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.

Other: 60-minute walking testDiagnostic Test: Static blood testDiagnostic Test: Post-effort blood testOther: ElectrocardiogramOther: Blood pressure monitoring

Interventions

60-minute walking testOTHER

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.

Control groupIndividual reproducibility" subgroup: controlsIndividual reproducibility" subgroup: patientsPatients
Static blood testDIAGNOSTIC_TEST

33.3 ml of blood will be taken from each participant whilst at rest, before undergoing the 60-minute walking test

Control groupIndividual reproducibility" subgroup: controlsIndividual reproducibility" subgroup: patientsPatients
Post-effort blood testDIAGNOSTIC_TEST

33.3 ml of blood will be taken from each participant immediately after undergoing the 60-minute walking test.

Control groupIndividual reproducibility" subgroup: controlsIndividual reproducibility" subgroup: patientsPatients
ElectrocardiogramOTHER

An electrocardiogram will be carried out throughout the exercise period and during the first 30 minutes of recovery.

Control groupIndividual reproducibility" subgroup: controlsIndividual reproducibility" subgroup: patientsPatients
Blood pressure monitoringOTHER

Blood pressure will be monitored out throughout the exercise period and during the first 30 minutes of recovery.

Control groupIndividual reproducibility" subgroup: controlsIndividual reproducibility" subgroup: patientsPatients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, Occitanie, 30029, France

RECRUITING

Related Publications (1)

  • Gris JC, Guillotin F, Dos Santos TP, Chea M, Loubet P, Laureillard D, Sotto A, Muller L, Barbar SD, Roger C, Lefrant JY, Jung B, Klouche K, Mura T, Quere I, Perez-Martin A. Prognostic value of an automated thrombin generation assay in COVID-19 patients entering hospital: A multicentric, prospective observational study. Thromb Res. 2023 Feb;222:85-95. doi: 10.1016/j.thromres.2022.12.019. Epub 2023 Jan 2.

    PMID: 36608393BACKGROUND

MeSH Terms

Conditions

Venous ThromboembolismMotor Activity

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and Supplies

Study Officials

  • Antonia PEREZ MARTIN, Prof.

    Nîmes University Hospital

    PRINCIPAL INVESTIGATOR

  • Stéphane FAURE

    Nîmes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia PEREZ MARTIN, Prof.

CONTACT

+334 66 68 33 13antonia.perez.martin@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236drc@chu-nimes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a single-center, prospective, cross-sectional, proof-of-concept study,
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 17, 2024

Study Start

February 11, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

FR(1)