Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-28
Brief Title:
Variations in the Hemostatic System Induced by a Standardized Walking Test
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
Official Title:
Variations in the Hemostatic System Induced by a Standardized Walking Test Controls vs Cases With a History of Non-anticoagulated Venous Thromboembolic Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FASTTHROMBIN
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
Detailed Description:
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 11
The Patients group comprises 47 patients with a personal history of induced venous thromboembolism the last event dating back to more than 6 months whose clinical phenotype did not justify long-term antithrombotic drug prophylaxisThe Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives
The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants Controls and Patients
- Intra-individual reproducibility will be analyzed in 20 subjects 10 patients and 10 controls who will take the walking test twice on two separate days
Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department Vascular Medicine Consultation or Biological Hematology and ConsultationsInclusion and non-inclusion criteria will be checked and the study will be explained to participants patients and controlsPatients and controls will be systematically asked to take part in the variability analysis on a voluntary basis until 10 subjects per group have agreed to carry out the second test
The walking test is performed in the morning 2 hours after a standard breakfast on a treadmill It will be preceded by a clinical examination a resting 12-lead electrocardiogram and a brachial pressure measurement After a 3-minute warm-up and habituation period walking speed 25 km per hour with no incline the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold and of the order of 70 of the theoretical maximum value evaluated by Astrands formula 220-age so as to maintain aerobic exercise conditions of moderate intensity enabling prolonged effort to be maintained Blood samples will be taken from each participant whilst at rest before undergoing the 60-minute walking test in a sitting position and just after the exercise test
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 11
The Patients group comprises 47 patients with a personal history of induced venous thromboembolism the last event dating back to more than 6 months whose clinical phenotype did not justify long-term antithrombotic drug prophylaxisThe Control group comprises 47 patients with no personal history of venous thromboembolism and no family history of venous thromboembolism in first-degree relatives
The study intervention consists of an hour-long walking test and two blood tests in both groups for all participants Controls and Patients
- Intra-individual reproducibility will be analyzed in 20 subjects 10 patients and 10 controls who will take the walking test twice on two separate days
Patients will be selected during a venous thromboembolism follow-up consultation by a physician from either department Vascular Medicine Consultation or Biological Hematology and ConsultationsInclusion and non-inclusion criteria will be checked and the study will be explained to participants patients and controlsPatients and controls will be systematically asked to take part in the variability analysis on a voluntary basis until 10 subjects per group have agreed to carry out the second test
The walking test is performed in the morning 2 hours after a standard breakfast on a treadmill It will be preceded by a clinical examination a resting 12-lead electrocardiogram and a brachial pressure measurement After a 3-minute warm-up and habituation period walking speed 25 km per hour with no incline the speed and incline will be gradually increased until a target heart rate close to the theoretical ventilatory threshold and of the order of 70 of the theoretical maximum value evaluated by Astrands formula 220-age so as to maintain aerobic exercise conditions of moderate intensity enabling prolonged effort to be maintained Blood samples will be taken from each participant whilst at rest before undergoing the 60-minute walking test in a sitting position and just after the exercise test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None