Status:
COMPLETED
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease
Lead Sponsor:
University Hospital, Tours
Conditions:
Coronary Artery Disease
Inflammatory Response
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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...
Detailed Description
A multi-center, open-label, randomized delayed-start pilot study in 2 parallel groups will be conducted: participants will be randomized as to when the influenza vaccine will be administered, accordin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2024
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06508437
Start Date
October 21 2024
End Date
November 25 2024
Last Update
November 21 2025
Active Locations (1)
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1
Chru de Trousseau
Tours, France, 37000