Variations in the Hemostatic System Induced by a Standardized Walking Test

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

First year of combined oestrogen-progestogen oral contraception, or contraception using an oestrogen-impregnated vaginal ring or transcutaneous synthetic oestrogen patch.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 60-minute walking test

    Other intervention

    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.

  • Static blood test

    Diagnostic test

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

  • Post-effort blood test

    Diagnostic test

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

  • Electrocardiogram

    Other intervention

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

  • Blood pressure monitoring

    Other intervention

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

Treatment groups

94 Participants
are divided into 4 treatment groups
Group A: Control groupActive comparator 5 interventions
Group B: PatientsActive comparator 5 interventions
Group C: Individual reproducibility" subgroup: controlsActive comparator 5 interventions
Group D: Individual reproducibility" subgroup: patientsActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 0
2

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)

Time frame
Day 0
3

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

Time frame
Day 0
4

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

Time frame
Day 0

Secondary outcomes

1

Distribution in the Control group

Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Control group

Time frame
Day 0
2

Distribution in the Patient group

Measurements in nM.min-1 will be compared to elicit central tendency, dispersion and heterogeneity in the Patient group

Time frame
Day 0
3

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

Latency time in the absence of thrombomodulin will be measured in seconds in Controls.

Time frame
Day 0
4

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

Thrombin peak intensity in the absence of thrombomodulin will be measured in Controls.

Time frame
Day 0

Other outcomes

1

Age in Controls

Ages will be recorded in years

Time frame
Day 0
2

Sex in Controls

Sex will be recorded as Male/Female/Non-binary

Time frame
Day 0
3

Body mass index in Controls

Body mass index of controls will be recorded in units of kg/m²

Time frame
Day 0
4

Age in Patients

Ages will be recorded in years

Time frame
Day 0

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