Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- The right coronary artery
研究概览
简要总结
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.
详细描述
Following informed consent patients are randomized in a 1:1 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Has received influenza vaccination within 6 months
- •Other vaccination planned within 8 weeks (including covid-19 booster doses)
- •Severe allergy to eggs or previous allergic reaction to influenza vaccine
- •Cardiac surgery or staged PCI planned within 8 weeks
- •Coronary stent involving the proximal RCA
- •Suspicion of febrile illness or acute, ongoing infection
- •Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol
- •Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response
- •Inability to provide informed consent
- •Previous randomization in the ELIMINATE trial
- •Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.
- •Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment [eGFR <30 mL/min/1.73 m2])
- •Atrial fibrillation
- •Uncontrolled chronic inflammatory disease
- •Unable to comply with protocol requirements
研究组 & 干预措施
Placebo arm
Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01
干预措施: Placebo (Biological)
Vaccination arm
Influenza vaccine (Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02)
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
The right coronary artery
时间窗: Between baseline and 8 weeks follow up.
Primary endpoint definition is a difference in pericoronary adipose tissue density (perivascular fat attenuation index) around the right coronary artery (RCA) measured by repeated CCTA imaging
次要结局
- Ascending aorta(Between baseline and 8 weeks follow up.)
- N-terminal pro-B-type natriuretic peptide(At 8 weeks follow up.)
- Interleukin Interleukin-6 (IL-6 )(Between baseline and 8 weeks follow up.)
- The whole coronary tree(Between baseline and 8 weeks follow up.)
- Ferritin(Between baseline and 8 weeks follow up.)
- Troponin-I(At 8 weeks follow up.)
- Interleukin 1 beta (IL-1β)(Between baseline and 8 weeks follow up.)
- Tumor necrosis factor alpha (TNF-α)(Between baseline and 8 weeks follow up.)
- Interleukin-2 receptor (IL-2r)(Between baseline and 8 weeks follow up.)