Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable C… (NCT06508437) | Clinical Trial Compass
CompletedPhase 4
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease
France47 participantsStarted 2024-10-21
Plain-language summary
Observational and randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Beyond classical view of indirect effect, linked to the neutralisation of the virus, it is currently considered whether the vaccination may have a direct effect on inflammatory process.Atherosclerosis is known to be driven both by lipid stress and inflammation both at local and systemic level. The investigators suggest that influenza vaccination could have a positive effect on atherosclerosis by regulating plasma inflammation. The aim of this pilot study is therefore to assess the impact of influenza vaccination in patients with stable coronary artery disease on the circulating inflammatory response, in order to validate its potential immunomodulatory effect. If it is found to be beneficial, it could also constitute a future adjuvant therapeutic tool to traditional pharmacotherapy in the prevention of cardiovascular events.
Who can participate
Age range
60 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:
* Subjects aged ≥ 60 years.
* With documented stable coronary artery disease.
* Subjects who, in the opinion of the investigator, can comply with the protocol requirements (i.e., show up for the follow-up visit and be able to converse with study staff).
* Signature of free, written and informed consent by the patient.
* Affiliation to a French social security system.
Exclusion Criteria:
* History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination.
* Participant has received the influenza vaccine within \<6 months or another vaccine.
* Acute infection within \<3 months or acute worsening of chronic diseases.
* Severe neurocognitive disorders (inability to give informed consent).
* Pre-existing medical conditions or medications involving the immune system (rheumatoid arthritis or other inflammatory conditions or active cancer, recent use (within the past year) of immunosuppressive or modulating agents, including oral steroids, chemotherapy, or radiation therapy) .
* Cardiovascular surgery or other interventions within 6 months preceding the study or planned during the follow-up period.
* Patient's wish or clinical situation requiring co-administration with other vaccines or any factor hindering monitoring.
* Patient under guardianship, curatorship or safeguard of justice.
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.
What they're measuring
1
Plasma concentration of high-sensitivity C-reactive protein (hsCRP)