NCT04581057

Brief Summary

This study aims at evaluating the prevalence of Clonal Hematopoiesis of Indeterminate Potential (CHIP) in patients over 75 presenting with a first cardio-vascular event (CVE). The investigators will also determine if CHIPs are more frequent in this population compared to a control cohort without CVE. An association between CHIP, a systemic inflammation and increased atherosclerosis will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 23, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2021

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

October 2, 2020

Last Update Submit

February 21, 2022

Conditions

Myocardial Infarction

Keywords

CHIPCardiovascular eventsAtherosclerosisInflammation

Outcome Measures

Primary Outcomes (1)

  • Presence of a CHIP

    Defined as the presence of a mutation (in the genes DNMT3A, TET2, ASXL1, SF3B1, TP53, CBL, SRSF2, GNB1 and PPM1D) (with an allelic frequency greater than 2, 5 or 10%).

    Day 1

Secondary Outcomes (4)

  • Frequency of CHIP

    Day 1

  • Assessment of systemic inflammation

    Day 1

  • Assessment of Atherosclerosis level

    Day 1

  • Presence of cardiovascular risk factor

    Day 1

Study Arms (1)

First CVE

EXPERIMENTAL
Biological: Specific blood sampling

Interventions

Specific blood samplingBIOLOGICAL

A 30 ml blood sample (6 EDTA tubes) will be taken at inclusion in the study, in addition to the blood sample taken as part of the routine care. This sampling is carried out for : * Search for CHIP-associated mutations in circulating leukocytes * Plasma determination of IL-1β, IL-6, IL-10 and TNF-α

First CVE

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients (male or female) over 75 years old
  • Absence of evidence of hematological malignancy (known or obvious by the results of blood counts)
  • Subject registered with a social security scheme
  • Written informed consent obtained

You may not qualify if:

  • Patients who did not presented any CVE in the last 7 months
  • Patients with CVE with a non-atheromatous origin (dissection, embolic, …)
  • Presence of an unbalanced diabetes (defined as HbA1C \> 10%)
  • History of previous CVE before 75 year-old : myocardial infarction, stroke of atheromatous origin
  • Hematological malignancy (known or obvious on the results of blood counts)
  • Chronic inflammatory disease (cancer, vasculitis, rheumatism, hepato-gastro-intestinal diseases).
  • Long term anti-inflammatory treatments:
  • Corticoids
  • Nonsteroidal anti-inflammatory drugs
  • Aspirin (\> 325 mg per day)
  • Cyclo-oxygenase II inhibitors
  • Persons under judicial safeguards, trustee or curators
  • Person deprived of judicial or administrative freedom
  • Person unable to give her consent
  • Non-cooperative person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

Related Publications (1)

  • Fawaz S, Marti S, Dufossee M, Pucheu Y, Gaufroy A, Broitman J, Bidet A, Soumare A, Munsch G, Tzourio C, Debette S, Tregouet DA, James C, Mansier O, Couffinhal T. Evaluation of clonal hematopoiesis and mosaic loss of Y chromosome in cardiovascular risk: An analysis in prospective studies. Elife. 2024 Dec 12;13:RP96150. doi: 10.7554/eLife.96150.

    PMID: 39665621DERIVED

MeSH Terms

Conditions

Myocardial InfarctionAtherosclerosisInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Thierry COUFFINHAL, MD-PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 9, 2020

Study Start

June 23, 2020

Primary Completion

October 3, 2021

Study Completion

October 3, 2021

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)