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Study on the Effect of Influenza Vaccine on Heart Inflammation After Heart Attack for Patients with Myocardial Infarction

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the flu vaccine, known as VaxigripTetra, on patients who have experienced a myocardial infarction, commonly known as a heart attack. The study aims to understand how the flu vaccine might influence inflammation in the heart following a heart attack. The flu vaccine used in this study contains inactivated strains of the influenza virus, including Influenza Virus A/Darwin/9/2021 (H3N2) and Influenza A/Victoria/4897/2022 (H1N1). Additionally, a solution called Sodium Chloride is used in the study.

The purpose of the study is to compare the effects of the flu vaccine with a placebo in reducing inflammation in the heart after a heart attack. Participants in the study will receive either the flu vaccine or a placebo. The study will monitor changes in heart inflammation over a period of eight weeks. This will be done using a special imaging technique called computed tomography (CT), which helps visualize the heart and surrounding tissues.

Throughout the study, various health markers will be measured to assess the impact of the flu vaccine on heart inflammation. These include changes in specific proteins and cells in the blood that are related to inflammation. The study will also look at other indicators of heart health, such as levels of certain proteins that are released when the heart is under stress. The trial is expected to continue until 2027, with recruitment starting in 2024.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as a recent diagnosis of non-ST-segment elevation myocardial infarction and completion of a coronary PCI procedure.
Participants must be male or non-fertile female subjects aged 18 years or older, and must provide written informed consent.
Step 2
Initial assessment
A CCTA scan is scheduled within 7 days after the PCI procedure to establish baseline measurements of coronary inflammation.
Step 3
Administration of treatment
Participants receive either the influenza vaccine, VaxigripTetra, or a placebo. The vaccine is administered as a suspension for injection via the intramuscular route.
The vaccine contains inactivated influenza viruses and sodium chloride as a solution for infusion.
Step 4
Monitoring and follow-up
Participants are monitored for changes in coronary inflammation, specifically the pericoronary adipose tissue density, using CCTA at week 8.
Secondary assessments include changes in the average PCAT density of the coronary tree, perivascular adipose tissue density of the ascending aorta, and various markers of systemic inflammation.
Step 5
Final evaluation
At the end of the 8-week period, a final evaluation is conducted to assess changes in cardiac biomarkers and exploratory endpoints such as differences in immune cell subpopulations and blood proteome.

Who can join the trial?

5 criteria

Patients must have a diagnosis of non-ST-segment elevation myocardial infarction, which is a type of heart attack.
Patients must have completed a coronary PCI, which is a procedure to open up blood vessels in the heart.
Participants can be male or non-fertile female subjects who are 18 years or older. Non-fertile females include those who cannot become pregnant, such as postmenopausal women or women who have had a hysterectomy.
Participants must provide written informed consent, meaning they agree to join the study after being fully informed about it.
A CCTA scan, which is a special heart scan, must be able to be scheduled within 7 days after the PCI procedure.

Who cannot join the trial?

4 criteria

Individuals who have had a myocardial infarction, which is commonly known as a heart attack.
People who are not within the specified age range for the study.
Participants who do not fit into the specific clinical trial groups required for the study.
Individuals who are part of a vulnerable population, meaning they might need special protection or care.

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Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Influenza Vaccine The influenza vaccine is used in this trial to see if it can help reduce inflammation in the heart after a heart attack. The vaccine is typically used to protect against the flu, but researchers are investigating whether it might also have benefits for heart health by reducing inflammation.

What is already known about the treatment

Influenza Vaccine – This medication is administered via injection, typically into the muscle of the upper arm. It is currently well-established in medical practice and literature as a preventive measure against influenza. In the context of the ELIMINATE trial, its main therapeutic indication is to reduce coronary inflammation following a myocardial infarction. The vaccine works by stimulating the immune system to produce antibodies against the influenza virus, thereby reducing the risk of infection and potentially decreasing inflammation in the heart. It is classified as a vaccine under pharmacological categories.

Investigated diseases

Myocardial Infarction – Myocardial infarction, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is often due to a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. As the plaque breaks, a blood clot forms, which can obstruct the flow of blood. Symptoms may include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression of the disease can lead to complications such as heart failure or arrhythmias if not managed properly.