IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- The presence/absence of an activation profile
Study Overview
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?
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The presence/absence of an activation profile
Time Frame: 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 Outcomes
- The presence / absence of a constitutional biological thrombophilia(Day (0))
- Fibrin monomer (blood; mg/ L)(Day (0))
- History of proximal deep vein thrombosis? yes/no(Day (0))
- History of placental vascular pathology? yes/no(Day (0))
- The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies(Day (0))
- Blood D-dimers (ng/mL)(Day (0))
- History of pulmonary embolism? yes/no(Day (0))
- The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies(Day (0))
- The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies(Day (0))