Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508437
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease - Randomized Delayed-Start Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVAMI
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 the neutralisation of the virus it is currently considered whether the vaccination may have a direct effect on inflammatory processAtherosclerosis 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
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 according to a 11 ratio between influenza vaccination immediately after inclusion or at 1-month follow-up Blood tests for plasmatic inflammation analyses will be collected at baseline and at 1 month after study inclusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None