IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism (ActiMon)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Pulmonary Embolism; Venous Thromboembolism

Treatments: Biological: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT02713581

2016-A00447-44 (Other Identifier)

AOI/2015/SB-01

Details and patient eligibility

About

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.

Full 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?

Enrollment: 34 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

34 participants in 2 patient groups

Women with proximal VTE

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. Intervention: Blood sampling

Treatment:

Biological: Blood sampling

Women with >1 healthy pregnancy

Description:

This populations is composed of healthy, female, adult volunteers (\<50 years in age) that have had at least 1 healthy pregnancy. Intervention: Blood sampling

Treatment:

Biological: Blood sampling