Evaluation of Two New Innovative Haemostasis Tests: Measurement of the Active Form of GTP-bound Rap1b (aRap1b) in Platelets and the Pro and Antithrombotic Balance of Circulating Endothelial Microvesicles (patEMV) (INNOV-CKD Test)

NCT05765630 | Unknown

• 2 other identifiers: RCAPHM20_03282020-A01264-35_
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Reproducibility of pat EMV

  1 year

• Repeatability

  1 year

• Analytical specificity

  1 year

• Range of values in each group

  1 year

Study Arms (5)

Healthy patients

ACTIVE COMPARATOR

Biological: BLOOD SAMPLES

CKD patients not receiving antiplatelet agents

EXPERIMENTAL

Biological: BLOOD SAMPLES

CKD patients receiving antiplatelet agents

EXPERIMENTAL

Biological: BLOOD SAMPLES

Patients with constitutional thrombopathy with RAP1B activation defect

EXPERIMENTAL

Biological: BLOOD SAMPLES

Patients with ACS in the previous month treated with antiplatelet agents

EXPERIMENTAL

Biological: BLOOD SAMPLES

Interventions

BLOOD SAMPLES BIOLOGICAL

BLOOD SAMPLES

CKD patients not receiving antiplatelet agents; CKD patients receiving antiplatelet agents; Healthy patients; Patients with ACS in the previous month treated with antiplatelet agents; Patients with constitutional thrombopathy with RAP1B activation defect

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13008, France

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurent BONELLO, Pr.

  Service cardiologie Hopital Nord

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephane BURTEY, Pr.

CONTACT

+33(0)634603257; stephane.burtey@univ-amu.fr

Alexandra GIULIANI

CONTACT

+33(0)491382870; alexandra.giuliani@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: March 13, 2023
• Study Start: March 8, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

FR (1)