Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with a diagnosis of non-ST-segment elevation myocardial infarction

• A finalized coronary PCI

• Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)

• Written informed consent

• A CCTA can be scheduled within 7 days after PCI

Locations
Other Locations
Denmark
Aarhus University Hospital, Department of Cardiology
RECRUITING
Aarhus
Sweden
Örebro University Hospital
RECRUITING
Örebro
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Contact Information
Primary
Sara Cajander, MD
sara.cajander@oru.se
+46196021042
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2027-12
Participants
Target number of participants: 90
Treatments
Active_comparator: Vaccination arm
Influenza vaccine (Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02)
Placebo_comparator: Placebo arm
Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01
Sponsors
Collaborators: University of Cambridge, The Swedish Heart and Lung Association, Cambridge University Hospitals NHS Foundation Trust, Örebro University, Sweden, Aarhus University Hospital
Leads: Region Örebro County

This content was sourced from clinicaltrials.gov