RecruitingPHASE4INTERVENTIONAL

Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE

This research trial is investigating whether getting a standard flu vaccine can help reduce inflammation in the heart and blood vessels after someone has had a recent heart attack. We know that inflammation plays a role in heart conditions, and the flu itself can be very hard on the heart. Participants will either receive the flu vaccine or a placebo (a dummy shot) shortly after their heart attack treatment. Researchers will then use special scans and blood tests to measure any changes in inflammation over eight weeks. The main goal is to see if the flu vaccine helps cool down this inflammation, potentially leading to better recovery and long-term heart health.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Region Örebro County

Enrolment target

Start

24 Apr 2024

Estimated completion

01 Dec 2027

Acute Myocardial Infarction Cardiovascular Diseases Inflammatory Response

What is this study about?

This study is looking into a really important question for people who have recently experienced a heart attack. After a heart attack, the body often has increased inflammation, which is a natural response but can also be harmful to the heart and blood vessels if it goes on for too long. We also know that having the flu can put extra stress on the heart and worsen existing heart conditions.

The main idea behind this research is to see if getting a flu vaccine, even outside of flu season, might do more than just protect you from the flu. Researchers believe it could also help reduce this inflammation in your arteries, making your recovery process smoother. To find this out, some participants will receive a flu vaccine, while others will get a placebo (a harmless shot that looks just like the vaccine but contains no active medicine). This allows the researchers to fairly compare the effects of the vaccine and understand if any changes are truly due to the vaccine itself.

Throughout the study, doctors will use special imaging techniques, like heart scans, to precisely measure inflammation in the arteries around your heart. They will also take blood samples to look for markers of inflammation in your body. By comparing these measurements before and after the vaccine or placebo, they hope to understand if the flu vaccine has a positive impact on heart health by reducing inflammation after a heart attack. This information could eventually help doctors make better recommendations for people recovering from heart attacks.

Key takeaways

Tests if flu vaccine reduces heart inflammation after a heart attack.
Compares flu vaccine to a placebo (dummy shot).
Uses blood tests and special heart scans (CCTA) to measure inflammation.
Participation lasts about eight weeks after your heart attack treatment.
Aims to improve future care for heart attack patients.

Who may be eligible?

To join this study, you would need to be an adult (18 or older) who has recently had a specific type of heart attack (called a non-ST-segment elevation myocardial infarction) and has undergone a procedure to open up blocked heart arteries called a PCI. This study is open to men and women, but women would need to be past childbearing age or have a medical condition preventing pregnancy. You also need to be able to have a special heart scan called a CCTA within a week of your PCI.

There are several reasons why you might not be able to join. For example, if you've had a flu vaccine in the last six months, or if you plan to have other vaccinations (like a COVID-19 booster) within eight weeks. People with severe allergies to eggs or flu vaccine ingredients, or those with certain medical conditions like atrial fibrillation, active infections, or serious kidney problems, would also not be able to participate. If you have an illness that might affect your immune system, or if you can't have the heart scan for any reason, you also wouldn't be able to take part.

Quick self-check

I'm 18 years or older.
I've recently had a specific type of heart attack and a heart artery procedure (PCI).
I haven't had a flu vaccine in the last 6 months and don't plan other vaccines within 8 weeks.
I don't have severe allergies to vaccine ingredients (like eggs).
I can have a special heart scan (CCTA).

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, here's what you can expect: * **Random Assignment:** You will be randomly assigned, like flipping a coin, to receive either a standard flu vaccine or a placebo (a dummy shot that looks identical) within seven days of your heart artery procedure (PCI). * **Blood Samples:** You'll have blood samples taken at the beginning of the study (before vaccination) and again eight weeks later. These samples will help researchers understand how your immune system is responding. * **Heart Scans:** You will undergo two special heart scans, called CCTA (Coronary Computed Tomography Angiography). The first scan will be done within seven days of your heart attack, and the second scan will be eight weeks later. These scans help measure inflammation in your heart arteries. * **Total Duration:** Your active participation in the study will last for approximately eight weeks, from the time you receive the vaccine or placebo until your final blood tests and heart scan.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information gained could help many people who have heart attacks in the future. Potential benefits could include receiving a flu vaccine which can help protect you from the flu, though some participants will receive a placebo. Potential risks are generally low, similar to those associated with a standard flu jab (like a sore arm, fever, or aches), or with blood tests and heart scans (such as minor discomfort, bruising, or exposure to a small amount of radiation from the CT scan). You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Aarhus University Hospital, Department of Cardiology
Aarhus, Denmark· Recruiting
Örebro University Hospital
Örebro, Sweden· Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom· Recruiting

Common questions

What is 'inflammation' and why is it important after a heart attack?

Inflammation is your body's natural response to injury. After a heart attack, there can be a lot of inflammation in and around your heart, which can sometimes slow down healing or cause further problems.

What is a 'placebo'?

A placebo is a 'dummy' shot that looks exactly like the real vaccine but contains no active medicine. It helps researchers fairly compare results.

What is a 'CCTA' scan?

CCTA stands for Coronary Computed Tomography Angiography. It's a special type of X-ray scan that takes detailed pictures of your heart and the blood vessels supplying it, helping doctors see areas of inflammation.

Will I know if I received the flu vaccine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know whether you received the vaccine or the placebo until the study is over. This helps ensure fair results.

Will taking part affect my regular medical care?

No, taking part in this study will not affect your usual medical care. You can withdraw at any time without it impacting your treatment.

How to find out more

Sara Cajander, MD

sara.cajander@oru.se +46196021042 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.