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Идёт набор NCT06336317

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

Фаза IV С лечением Acute Myocardial Infarction Cardiovascular Diseases Inflammatory Response

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Influenza vaccine, Placebo.
Кому может быть актуально
Состояния в реестре: Acute Myocardial Infarction, Cardiovascular Diseases, Inflammatory Response. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания, Швеция, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Биопрепарат Influenza vaccine
    Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
  • Биопрепарат Placebo
    Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01

Первичные конечные точки

  • The right coronary artery [Срок оценки: Between baseline and 8 weeks follow up.]
Вторичные конечные точки (9)
  • The whole coronary tree [Срок оценки: Between baseline and 8 weeks follow up.]
  • Ascending aorta [Срок оценки: Between baseline and 8 weeks follow up.]
  • Interleukin 1 beta (IL-1β) [Срок оценки: Between baseline and 8 weeks follow up.]
  • Tumor necrosis factor alpha (TNF-α) [Срок оценки: Between baseline and 8 weeks follow up.]
  • Interleukin-2 receptor (IL-2r) [Срок оценки: Between baseline and 8 weeks follow up.]
  • Interleukin Interleukin-6 (IL-6 ) [Срок оценки: Between baseline and 8 weeks follow up.]
  • Ferritin [Срок оценки: Between baseline and 8 weeks follow up.]
  • Troponin-I [Срок оценки: At 8 weeks follow up.]
  • N-terminal pro-B-type natriuretic peptide [Срок оценки: At 8 weeks follow up.]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Aarhus University Hospital, Department of Cardiology — Aarhus
Швеция · 1 центр
  • Örebro University Hospital — Örebro
Великобритания · 1 центр
  • Cambridge University Hospitals NHS Foundation Trust — Cambridge

Идентификаторы

NCT: NCT06336317 · ELIMINATE-2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗