Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Proximal venous thromboembolism
Brief summary
The primary objective of this study is to search for, in vitro, elements associated with IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant and pro-inflammatory factors) and to describe their prevalence in female patients with a history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) compared to control women.
Detailed description
The secondary objectives of this study include to compare the IgG-dependent monocyte activation profiles as a function of laboratory thrombophilia parameters. Essentially: Is IgG-dependent cell activation associated with the presence of anti-phospholipid antibodies (or their subtypes?), or do these profiles indicate something beyond the nosology of anti-phospholipid syndrome?
Interventions
BIOLOGICALBlood sampling
Venous blood will be sampled for laboratory analyses (see outcomes).
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
for patients: * The patient has given her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * Adult woman 18 to 50 years old * At least one prior incident of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) over three months ago regardless of the patient's history of placental vascular disease
Exclusion criteria
for patients: * The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, or is an adult under guardianship * It is impossible to correctly inform the patient, or the patient refuses to sign the consent * Postmenopausal women * Pregnancy within the last 3 months * Isolated history of superficial venous thrombosis * Isolated history of distal venous thrombosis * History of malignancy (solid or hematological) * Known positive serology for hepatitis B * Known positive serology for hepatitis C * Known positive serology for human immunodeficiency virus (HIV) * Episode of inflammatory or infectious disease dating back less than 3 months * Impaired liver function characterized by liver enzymes (Alanine aminotransferase/ Aspartate aminotransferase) greater than 3 times normal * Impaired renal function tests characterized by a glomerular filtration rate below 80 ml / min * Drug background therapy (other than antiplatelet or anticoagulant therapy) used in the treatment of autoimmune disease Inclusion Criteria for healthy volunteers: * The healthy volunteer has given her informed and signed consent * The healthy volunteer must be insured or beneficiary of a health insurance plan * Adult woman 18 to 50 years old * A history of at least one normal pregnancy defined by the birth of a child born alive in the absence of placental vascular complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The presence/absence of an activation profile | Day (0) | The following will be taken into account: Six signaling pathways (Protein kinase B, extracellular-signal-regulated kinases, Signal transducer and activator of transcription 5, P38 mitogen-activated protein kinases, Mechanistic Target Of Rapamycin, nuclear factor kappa-light-chain-enhancer of activated B cells), increases in the expression of tissue factor, and 5 pro-inflammatory factors (Intercellular Adhesion Molecule, tumor necrosis factor alpha, interferon gamma, Interleukin-1 beta, Interleukin 8). A pathway will be considered as activated or an expression profile as increased when the observed value is superior to the 95% confidence interval determined using healthy volunteer values. A patient is considered as having an activation profile if at least one of the above pathways or expressions is considered as activated / increased. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| History of pulmonary embolism? yes/no | Day (0) | — |
| History of placental vascular pathology? yes/no | Day (0) | — |
| The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies | Day (0) | — |
| The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies | Day (0) | — |
| History of proximal deep vein thrombosis? yes/no | Day (0) | — |
| The presence / absence of a constitutional biological thrombophilia | Day (0) | The presence / absence of a constitutional biological thrombophilia (mutation of the Leiden V factor and the prothrombin gene, deficiency in physiological coagulation inhibitors) |
| Fibrin monomer (blood; mg/ L) | Day (0) | — |
| Blood D-dimers (ng/mL) | Day (0) | — |
| The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies | Day (0) | — |
Countries
France
Outcome results
None listed