Effect of infLuenza vaccInation after Myocardial INfArction on cardiac inflammaTory responsE - a randomized, double-blind, placebo-controlled, trial (ELIMINATE trial)

Conditions

Myocardial infarction

Brief summary

Change from baseline in pericoronary adipose tissue (PCAT) density (right coronary artery), a marker of coronary artery inflammation measured by CCTA, at week 8.

Detailed description

Change from baseline in the average PCAT density of the whole coronary tree (main epicardial arteries ≥2mm), Change from baseline in the perivascular adipose tissue density of the ascending aorta, Differences in cytokine and chemokine profiles (including IL-1β, TNF-α, IL-2r, IL-6), and other markers of systemic inflammation, (ferritin and high sensitivity CRP) at baseline and 8 weeks follow up, Cardiac biomarkers (troponin-I, N-terminal pro-B-type natriuretic peptide) at 8 weeks follow up, Exploratory endpoints: Differences in myeloid, T- and B cell subpopulations, their activation status and their gene expression signatures, measured by mass cytometry and single-cell RNA sequencing, and differences in blood proteome, from baseline to 8 weeks.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGVaxigripTetra

DRUGinjektionsvätska

DRUGsuspension i förfylld spruta Fyrvalent influensavaccin (spjälkat virus

DRUGinaktiverat)

DRUGNatriumklorid B. Braun 9 mg/ml infusionsvätska

DRUGlösning

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in pericoronary adipose tissue (PCAT) density (right coronary artery), a marker of coronary artery inflammation measured by CCTA, at week 8.	—

Secondary

Measure	Time frame
Change from baseline in the average PCAT density of the whole coronary tree (main epicardial arteries ≥2mm), Change from baseline in the perivascular adipose tissue density of the ascending aorta, Differences in cytokine and chemokine profiles (including IL-1β, TNF-α, IL-2r, IL-6), and other markers of systemic inflammation, (ferritin and high sensitivity CRP) at baseline and 8 weeks follow up, Cardiac biomarkers (troponin-I, N-terminal pro-B-type natriuretic peptide) at 8 weeks follow up, Exploratory endpoints: Differences in myeloid, T- and B cell subpopulations, their activation status and their gene expression signatures, measured by mass cytometry and single-cell RNA sequencing, and differences in blood proteome, from baseline to 8 weeks.	—

Measure

Time frame

Change from baseline in the average PCAT density of the whole coronary tree (main epicardial arteries ≥2mm), Change from baseline in the perivascular adipose tissue density of the ascending aorta, Differences in cytokine and chemokine profiles (including IL-1β, TNF-α, IL-2r, IL-6), and other markers of systemic inflammation, (ferritin and high sensitivity CRP) at baseline and 8 weeks follow up, Cardiac biomarkers (troponin-I, N-terminal pro-B-type natriuretic peptide) at 8 weeks follow up, Exploratory endpoints: Differences in myeloid, T- and B cell subpopulations, their activation status and their gene expression signatures, measured by mass cytometry and single-cell RNA sequencing, and differences in blood proteome, from baseline to 8 weeks.

—

Countries

Denmark, Sweden

Outcome results

None listed