IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

NCT02713581 | Completed

• 2 other identifiers: AOI/2015/SB-012016-A00447-44
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Thromboembolism; Pulmonary Embolism

Keywords

Proximal venous thromboembolism

Outcome Measures

Primary Outcomes (1)

• The presence/absence of an activation profile

  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.

  Day (0)

Secondary Outcomes (9)

• History of proximal deep vein thrombosis? yes/no

  Day (0)

• 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)

Study Arms (2)

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

Biological: Blood sampling

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

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

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

Women with >1 healthy pregnancy; Women with proximal VTE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another interventional study, or has participated in another interventional study within the past 3 months
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Saint-Eloi

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sylvie Bouvier, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: January 3, 2017
• Primary Completion: January 3, 2019
• Study Completion: June 23, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

FR (2)