IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

NCT ID: NCT02713581

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 34 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2020-06-23

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?

Conditions

Venous Thromboembolism; Pulmonary Embolism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Women with proximal VTE

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

Blood sampling

Intervention Type: BIOLOGICAL

Venous blood will be sampled for laboratory analyses (see outcomes).

Women with >1 healthy pregnancy

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

Intervention: Blood sampling

Blood sampling

Intervention Type: BIOLOGICAL

Venous blood will be sampled for laboratory analyses (see outcomes).

Interventions

Blood sampling

Venous blood will be sampled for laboratory analyses (see outcomes).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvie Bouvier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2016-A00447-44

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2015/SB-01

Identifier Type: -

Identifier Source: org_study_id