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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00447-44 | Other Identifier | RCB number |
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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | Venous blood will be sampled for laboratory analyses (see outcomes). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria for patients:
Exclusion Criteria for patients:
Inclusion Criteria for healthy volunteers:
Exclusion Criteria for healthy volunteers:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Bouvier, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Saint-Eloi | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Day (0) |
| The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies | Day (0) |
| The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies | Day (0) |
| The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies | 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) | Day (0) |
| Fibrin monomer (blood; mg/ L) | Day (0) |
| Blood D-dimers (ng/mL) | Day (0) |
| Nîmes |
| 30029 |
| France |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |