Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease
NCT Number: NCT06508437
Acronym: IVAMI
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Coronary Artery Disease|Inflammatory Response|Atherosclerosis
Interventions: BIOLOGICAL: Influenza Vaccination
Sponsor: University Hospital, Tours
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-25
Completion Date: 2025-07-25
Locations: Chru de Trousseau, Tours, 37000, France

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.

Primary Outcome Measures: Plasma concentration of high-sensitivity C-reactive protein (hsCRP), Change from baseline in peripheral blood hsCRP concentrations (mg/L) between study group, Between baseline and 1-month follow up
Secondary Outcome Measures: Other Plasma inflammatory markers : Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 ), Change from baseline in peripheral blood markers: Tumor necrosis factor alpha (TNF-α), Interleukin 1 beta (IL-1β), Interleukin-6 (IL-6 ) concentrations (pg/mL) parbetween study group, Between baseline and 1-month follow up|Other Plasma inflammatory markers : N-terminal pro-B-type natriuretic peptide, Change from baseline in peripheral blood markers N-terminal pro-B-type natriuretic peptide concentrations (ng/L) between study group, Between baseline and 1-month follow up|Other Plasma inflammatory markers : fibrinogen, Change from baseline in peripheral blood markers: fibrinogen concentrations (g/L) between study group, Between baseline and 1-month follow up|Plasma arterial vulnerability markers, Change from baseline in peripheral blood markers (g/l) : Apolipoprotein B, lipoprotein(a) and low density lipoproteins cholesterol (LDLc) between study group, Between baseline and 1-month follow up|Immunoinflammatory markers in circulating immune cells : T cell response, Differences in the expression level of peripheral blood immune cells by reverse transcription and real-time PCR (RT-qPCR) of genes involved in the T-cell response (CD3, CD4, CD8) between study group., Between baseline and 1-month follow up|Immunoinflammatory markers in circulating immune cells : T cell population, Differences in the expression level of peripheral blood immune cells by reverse transcription and real-time PCR (RT-qPCR) of genes involved in the T-cell orientation : Th1 (Tbet), Th2 (GATA3), Th17 (RORγ), Treg (FOXP3) between study group., Between baseline and 1-month follow up|Circulating immune cells profile : percentage of peripheral immune cells, Differences in peripheral blood immune cells determined by flow cytometry from blood mononuclear cells (PBMC): Percentage of B lymphocytes (CD45+CD19+), T lymphocytes (CD45+CD3+) and monocytes (CD45+CD14+CD11c+) between study group., Between baseline and 1-month follow up