IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

Pulmonary Embolism Clinical Trial

— ActiMon  

Official title:

IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713581
• Other study ID #: AOI/2015/SB-01
• Secondary ID: 2016-A00447-44
• Status: Completed
• Start date: January 3, 2017
• Est. completion date: June 23, 2020

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 23, 2020
• Est. primary completion date: January 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Biological:
• Blood sampling
Venous blood will be sampled for laboratory analyses (see outcomes).

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Saint-Eloi	Montpellier cedex 5
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	History of proximal deep vein thrombosis? yes/no		Day (0)
Secondary	History of pulmonary embolism? yes/no		Day (0)
Secondary	History of placental vascular pathology? yes/no		Day (0)
Secondary	The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies		Day (0)
Secondary	The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies		Day (0)
Secondary	The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies		Day (0)
Secondary	The presence / absence of a constitutional biological thrombophilia	The presence / absence of a constitutional biological thrombophilia (mutation of the Leiden V factor and the prothrombin gene, deficiency in physiological coagulation inhibitors)	Day (0)
Secondary	Fibrin monomer (blood; mg/ L)		Day (0)
Secondary	Blood D-dimers (ng/mL)		Day (0)