Clinical trial NCT02713581: IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism
Official title: IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Pulmonary Embolism
Keywords: Proximal venous thromboembolism
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population description: Patients will correspond to cases of proximal venous thromboembolism. They will be recruited during consultations conducted for the chronic management of a history of proximal venous thromboembolism or thrombophilia following a recent history of proximal venous thromboembolism. Venous thromboembolism, outside of acute phase episodes, has good symptom stability over time; no difference is to be expected between patients with a chronic history of proximal venous thromboembolism and new patients coming in for a checkup. Note that these patients may or may not have a history of placental vascular disease.

Healthy volunteer population description: This populations is composed of healthy, female, adult volunteers (\<50 years in age) that have had at least 1 healthy pregnancy.

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?

Eligibility criteria: 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

Exclusion Criteria for healthy volunteers:

* The healthy volunteer is participating in another interventional study, or has participated in another interventional study within the past 3 months
* The healthy volunteer is in an exclusion period determined by a previous study
* The healthy volunteer is under judicial protection, or is an adult under guardianship
* It is impossible to correctly inform the healthy volunteer, or the healthy volunteer refuses to sign the consent
* Postmenopausal women
* Pregnancy within the last 3 months
* History of superficial venous thrombosis
* 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
* Background drug treatment
* History of proximal venous thromboembolism
* History of placental vascular disease

Primary outcomes:
measure: The presence/absence of an activation profile
timeFrame: Day (0)
Secondary outcomes:
measure: History of proximal deep vein thrombosis? yes/no
timeFrame: Day (0)
measure: History of pulmonary embolism? yes/no
timeFrame: Day (0)
measure: History of placental vascular pathology? yes/no
timeFrame: Day (0)
measure: The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies
timeFrame: Day (0)
measure: The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies
timeFrame: Day (0)
measure: The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies
timeFrame: Day (0)
measure: The presence / absence of a constitutional biological thrombophilia
timeFrame: Day (0)
measure: Fibrin monomer (blood; mg/ L)
timeFrame: Day (0)
measure: Blood D-dimers (ng/mL)
timeFrame: Day (0)
Other outcomes:
Locations:
city: Montpellier cedex 5
country: France
facility: CHRU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Sylvie Bouvier, MD
role: PRINCIPAL_INVESTIGATOR
References: