Venous ThromboembolismActiMonNCT02713581
IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism
An observational study of Venous Thromboembolism and Pulmonary Embolism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism, Pulmonary Embolism
- What is being tested?
- Blood sampling
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jan 2017to 23 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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.
Read the 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
- Being tested
- Blood sampling
- Keywords
- Proximal venous thromboembolism
- Medical subject headings
- Venous Thromboembolism, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Venous blood will be sampled for laboratory analyses (see outcomes).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day (0)
Secondary outcomes (9)
History of proximal deep vein thrombosis? yes/no
Measured: Day (0)
History of pulmonary embolism? yes/no
Measured: Day (0)
History of placental vascular pathology? yes/no
Measured: Day (0)
The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies
Measured: Day (0)
The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies
Measured: Day (0)
The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies
Measured: Day (0)
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)
Measured: Day (0)
Fibrin monomer (blood; mg/ L)
Measured: Day (0)
Blood D-dimers (ng/mL)
Measured: Day (0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start3 Jan 2017
- Primary completion3 Jan 2019
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Bouvier, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713581
- Sponsor's protocol ID
- AOI/2015/SB-01
- Other IDs
- 2016-A00447-44
- Acronym
- ActiMon
- Status last verified
- Jun 2020
- First submitted
- 15 Mar 2016
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT02713581
- Acronym / sponsor ID
- ActiMon / AOI/2015/SB-01
- Conditions
- Venous Thromboembolism, Pulmonary Embolism
- Keywords
- Proximal venous thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 3 Jan 2019 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with proximal VTE | – | Biological: Blood samplingPatients 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 |
| Women with >1 healthy pregnancy | – | Biological: Blood samplingThis populations is composed of healthy, female, adult volunteers (<50 years in age) that have had at least 1 healthy pregnancy. Intervention: Blood sampling |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (34 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingVenous blood will be sampled for laboratory analyses (see outcomes). | Biological | Women with >1 healthy pregnancy, Women with proximal VTE |
Primary outcome
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.
9 secondary outcomes
History of proximal deep vein thrombosis? yes/no
Time frame: Day (0)
History of pulmonary embolism? yes/no
Time frame: Day (0)
History of placental vascular pathology? yes/no
Time frame: Day (0)
The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies
Time frame: Day (0)
The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies
Time frame: Day (0)
The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies
Time frame: Day (0)
The presence / absence of a constitutional biological thrombophilia
Time frame: Day (0)
Fibrin monomer (blood; mg/ L)
Time frame: Day (0)
Blood D-dimers (ng/mL)
Time frame: Day (0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Bouvier, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Pulmonary Embolism, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence/absence of an activation profile (time frame: Day (0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.