Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-25 @ 4:35 PM
Study NCT ID:
NCT04581057
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2020-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Clonal Hematopoiesis, Cardio-vascular Events, Inflammation and Atherosclerosis
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Frequency of Clonal Hematopoiesis in Patients Over 75 With a First Cardio Vascular Event. Consequences on Inflammation and Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHATH
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.
Detailed Description:
Despite increasing knowledge on the pathophysiology of cardio-vascular diseases (in particular the role of inflammation in the development of atherosclerosis), predicting their occurrence remains largely difficult. Aging remains the most powerful factor for predicting the occurrence of myocardial infarction, independently from other identified risk factors. Few years ago, acquired mutations were described in the hematopoietic system of apparently healthy subjects. This phenomenon, now described as CHIP (Clonal Hematopoiesis of Indeterminate Potential) is more frequently observed in elderly people, and has been recently linked to an increased risk of cardio-vascular events. Experiments in mice demonstrated that these CHIPs are responsible for an inflammation that supports the development of atherosclerosis. However the link between CHIP, inflammation and atherosclerosis has never been demonstrated in humans.
In this study, the investigators will search for an increased frequency of CHIP in patients with a first cardio-vascular event (CVE). Seven months after the CVE, a blood sample will be taken. Mutations in the 9 most frequently mutated genes in CHIP will be evaluated by Next Generation Sequencing. Systemic inflammation will be evaluated by measurement of circulating levels of CRP, IL-1β, IL-6, IL-10 and TNF-α. Atherosclerosis will be evaluated via the volume of atherosclerotic plaques as assessed by 3D ultrasound analysis. The presence of CHIP will be correlated to traditional cardiovascular risk factors, systemic inflammation markers and the level of atherosclerosis. The investigators will also assess the relationship between the presence of CHIP and the risk of CVE reoccurrence.
In this study, the investigators will search for an increased frequency of CHIP in patients with a first cardio-vascular event (CVE). Seven months after the CVE, a blood sample will be taken. Mutations in the 9 most frequently mutated genes in CHIP will be evaluated by Next Generation Sequencing. Systemic inflammation will be evaluated by measurement of circulating levels of CRP, IL-1β, IL-6, IL-10 and TNF-α. Atherosclerosis will be evaluated via the volume of atherosclerotic plaques as assessed by 3D ultrasound analysis. The presence of CHIP will be correlated to traditional cardiovascular risk factors, systemic inflammation markers and the level of atherosclerosis. The investigators will also assess the relationship between the presence of CHIP and the risk of CVE reoccurrence.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: