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Completed

NCT Number: NCT02713581

IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

CHRU de Montpellier - Hôpital Saint-Eloi, Montpellier, France

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About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

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

Primary outcomes

  1. The presence/absence of an activation profile

    Time frame: Day (0)

    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.

Secondary outcomes

  1. History of proximal deep vein thrombosis? yes/no

    Time frame: Day (0)

  2. History of pulmonary embolism? yes/no

    Time frame: Day (0)

  3. History of placental vascular pathology? yes/no

    Time frame: Day (0)

  4. The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies

    Time frame: Day (0)

  5. The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies

    Time frame: Day (0)

  6. The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies

    Time frame: Day (0)

  7. The presence / absence of a constitutional biological thrombophilia

    Time frame: Day (0)

    The presence / absence of a constitutional biological thrombophilia (mutation of the Leiden V factor and the prothrombin gene, deficiency in physiological coagulation inhibitors)

  8. Fibrin monomer (blood; mg/ L)

    Time frame: Day (0)

  9. Blood D-dimers (ng/mL)

    Time frame: Day (0)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: ActiMon

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 18, 2016
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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