Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336317
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-03-14
Brief Title:
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
Sponsor:
Region Örebro County
Organization:
Region Örebro County
Study Overview
Official Title:
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized Double-blind Placebo-controlled Trial ELIMINATE Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIMINATE
Brief Summary:
The goal of this randomized double-blind placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction AMI The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography CCTA The main questions it aims to answer are
Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention PCI in comparison to baseline Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline Researchers will compare the effects of influenza vaccination with those of a placebo
Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention PCI in comparison to baseline Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline Researchers will compare the effects of influenza vaccination with those of a placebo
Detailed Description:
Following informed consent patients are randomized in a 11 fashion to influenza vaccination or placebo up to 7 days following PCI Blood tests for immune cell phenotyping and transcriptomic and proteomic analyses will be collected at baseline and 8 weeks after study inclusion Patients will undergo CTCA at baseline 7 days of an AMI and 8 weeks after PCI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None