Correlation Between Clonal Hematopoiesis, Cardio-vascular Events, Inflammation and Atherosclerosis (NCT04581057) | Clinical Trial Compass
CompletedNot Applicable
Correlation Between Clonal Hematopoiesis, Cardio-vascular Events, Inflammation and Atherosclerosis
France114 participantsStarted 2020-06-23
Plain-language 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.
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients (male or female) over 75 years old
* Patients with a first CVE (myocardial infarction) of atheromatous origin that occurred between 2 and 7 months before inclusion
* 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
Exclusion Criteria:
* 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
* Exclusion period after another clinical study or participation to another interventional clinical study testing a drug in the 30 days before inclusion
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.