NCT07364058

Brief Summary

The leading cause of death is cardiovascular diseases in occidental countries. Of those, atherosclerosis is the major contributor to this burden being notably responsible for strokes and myocardial infarctions. The genesis of atherosclerosis is linked to both lipid accumulation and inflammation in the vascular wall of major arteries. One of the major pathways of inflammation is the TGF-beta axis which is at least partially regulated by the GARP protein. It has been investigated mostly in cancer biology but data in cardiovascular disease is lacking. Thus, the investigators aim to characterize the contribution of this protein by investigating its expression in tissue from patients with atherosclerosis, the carotid or femoral plaque representing a good source of residual material adequate for research purpose. The main cells expressing the GARP protein are the platelets and the T regulating cells which will be the main focus.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Jan 2029

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 15, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

AtheromaAtherosclerosisGARPLRRC32

Outcome Measures

Primary Outcomes (1)

  • GARP Expression in Platelets

    The number of cells/area expressing the GARP protein will be assessed

    Throughout the entire study, approximately during 3 years

Secondary Outcomes (2)

  • GARP Expression T Regulating Cells

    Throughout the entire study, approximately during 3 years

  • GARP Expression General

    Throughout the entire study, approximately during 3 years

Study Arms (1)

Endarterectomy population

This group includes patients with significant atherosclerotic burden justifying a surgical intervention of carotid or femoral endarterectomy.

Other: Tissue sample and data collection

Interventions

Tissue sample and data collection

Endarterectomy population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will comprise patients undergoing femoral or carotid endarterectomy in our tertiary care center (Cliniques Universitaires Saint-Luc) for atherosclerotic disease who do not meet exclusion criteria.

You may qualify if:

  • Older than 18 years
  • Able to give informed consent
  • Undergoing carotid or femoral endarterectomy

You may not qualify if:

  • Younger than 18 years
  • Pregnant
  • Dialysis
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

The plaques extracted from carotid or femoral endarterectomy will be used or all analysis.

MeSH Terms

Conditions

Carotid Artery DiseasesAtherosclerosisPlaque, Atherosclerotic

Interventions

Histocompatibility TestingData Collection

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Christophe Beauloye, Medical Degree

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis Charki, Medical Degree

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations