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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01264-35_ | Other Identifier | IDRCB |
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The aim of this PROJECT is to develop two biomarkers to assess the thrombotic and hemorrhagic risk of patients with chronic renal failure (CKD) treated with antiplatelet drugs following the occurrence of an acute coronary syndrome (ACS). These biomarkers will help to adapt antiplatelet therapy on an individual basis (intensity, duration of antiplatelet treatment) and thus reduce the risk of thrombotic and hemorrhagic events in this particularly fragile population. The methods for measuring these two highly innovative biomarkers are currently being developed. The first biomarker corresponds to the measurement of an intraplatelet molecule, Rap1b in its active form (aRap1b). The second biomarker is the measurement of the pro-antithrombotic balance of circulating endothelial microvesicles (patEMV), a reflection of endothelial dysfunction. An automated method for biomarker measurement will be developed in partnership with the industrial partners Stago and BioCytex during the project.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy patients | Active Comparator |
| |
| CKD patients not receiving antiplatelet agents | Experimental |
| |
| CKD patients receiving antiplatelet agents | Experimental |
| |
| Patients with constitutional thrombopathy with RAP1B activation defect | Experimental |
| |
| Patients with ACS in the previous month treated with antiplatelet agents | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLOOD SAMPLES | Biological | BLOOD SAMPLES |
|
| Measure | Description | Time Frame |
|---|---|---|
| aRap1b assay reproducibility | intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of aRap1b-GTP for subjects from groups 1, 2, 3, and 5. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of pat EMV | intraclass correlation coefficient and its 95% confidence interval (CI) for assessing the reproducibility over time of microvesicle derived functional assays for subjects from groups 1, 2, 3, and 5. | 1 year |
| Repeatability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephane BURTEY, Pr. | Contact | +33(0)634603257 | stephane.burtey@univ-amu.fr | |
| Alexandra GIULIANI | Contact | +33(0)491382870 | alexandra.giuliani@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Laurent BONELLO, Pr. | Service cardiologie Hopital Nord | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Recruiting | Marseille | 13008 | France |
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Coefficient of variation will be determined for different levels of concentration of the analytes (aRap1b resting and activates states and pat EMV)
| 1 year |
| Analytical specificity | Best threshold values between samples containing the analyte (aRap1B) compared to negative samples which do not contain the analyte. | 1 year |
| Range of values in each group | Mean, standard deviation, median, interquartile range | 1 year |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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