NCT06508437CompletedPhase 4
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 12 Jul 2024
- Start date
- 21 Oct 2024
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- University Hospital, Tours
- Diseases
- Coronary artery disease
- NCT number
- NCT06508437
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 47
- From 21 Oct 2024 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received the influenza vaccine within \<6 months or another vaccine.
- 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.
Other illness
- History of serious reaction to influenza vaccine or refusal of vaccination or contraindication to vaccination.
- 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) .
Other
- Patient under guardianship, curatorship or safeguard of justice.
Who the study is looking for
- 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.
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chru de Trousseau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.