Chronic Renal Failure
Conditions
Brief summary
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.
Interventions
BIOLOGICALBLOOD SAMPLES
BLOOD SAMPLES
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy subjects (group 1): DFG\>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security. * Antiplatelet agents-naïve CKD patients (group 2): DFG\<30 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Affiliated to social security. * CKD patients receiving antiplatelet agents (group 3): DFG\<30 ml/mn/1.73m2 in CKD-EPi, receiving antiplatelet agents, Age 18-85 years old, consent required, Affiliated with social security. * Patients with constitutional platelet dysfunction (group 4): DFG\>70 ml/min/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Constitutional haemorrhagic syndrome * Coronary patients (group 5): DFG\>70 ml/mn/1.73m2 in CKD-EPi, Age 18-85 years old, Consent required, Social Security Affiliated, Acute Coronary Syndrome in the previous month requiring AAP.
Exclusion criteria
* For all the groups : subjects refusing to participate in the study, pregnant or breastfeeding women, minors (except for special consent), adults subject to a legal protection measure or unable to express their consent (persons under guardianship or curatorship), persons deprived of their rights of liberty by judicial or administrative decision (persons in a situation of social fragility), persons at the end of life.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aRap1b assay reproducibility | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of pat EMV | 1 year | 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. |
| Repeatability | 1 year | Coefficient of variation will be determined for different levels of concentration of the analytes (aRap1b resting and activates states and pat EMV) |
| Analytical specificity | 1 year | Best threshold values between samples containing the analyte (aRap1B) compared to negative samples which do not contain the analyte. |
| Range of values in each group | 1 year | Mean, standard deviation, median, interquartile range |
Countries
France
Contacts
Primary ContactStephane BURTEY, Pr.
Backup ContactAlexandra GIULIANI
Outcome results
None listed