RecruitingOBSERVATIONAL

Prospective Evaluation of the Biomechanical Properties of the Thoracic Aorta Coupling Magnetic Resonance Imaging and In-vitro Elasticity Tests in Patients With Ascending Aortic Aneurysm

This research wants to understand more about the strength and flexibility of the main artery that leaves your heart, called the aorta. Specifically, it focuses on people who have a bulge (aneurysm) in the upper part of their aorta and are already scheduled for surgery to fix it. The study uses special magnetic resonance imaging (MRI) scans and tests on small tissue samples after surgery to learn about the aorta's properties. By understanding these properties better, doctors hope to improve how they decide who needs surgery, when it should happen, and how they monitor patients with these conditions. This could lead to better care for people with aortic aneurysms.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier Universitaire Dijon

Enrolment target

200

Start

17 Dec 2018

Estimated completion

01 Feb 2027

Patient With Ascending Aortic Aneurysm With Surgical Indication for Replacement

What is this study about?

This study is about understanding the aorta, which is the body's largest blood vessel. It carries blood from your heart to the rest of your body. Sometimes, a part of the aorta can weaken and bulge, like a balloon, which is called an aneurysm. This study focuses on people who have an aneurysm in the upper part of their aorta (the ascending aorta) and are already preparing to have surgery to repair it.

The main goal is to look closely at how strong and flexible the aorta is. Doctors don't fully understand these 'biomechanical' properties yet. To do this, they will use a special type of scan called an MRI (Magnetic Resonance Imaging), which takes detailed pictures of the inside of your body. They also plan to do tests on small pieces of the aortic tissue once it has been removed during surgery. These are called 'in-vitro elasticity tests' and help measure how stretchy the tissue is.

By gathering this information, the researchers hope to get a much clearer picture of what makes an aorta with an aneurysm behave the way it does. This knowledge is really important because it could help doctors make better decisions about when someone with an aortic aneurysm needs surgery, and how they monitor the condition over time. Ultimately, this research aims to improve the care and outcomes for patients like you.

Key takeaways

Study aims to understand the strength and stretchiness of the aorta.
Focuses on people with an aortic aneurysm needing surgery.
Uses a special MRI scan and tissue tests after surgery.
Does not change your planned medical treatment or surgery.
Aims to improve future care for aortic aneurysm patients.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or older, and have an aneurysm in the upper part of your aorta. Importantly, you would already need to be scheduled for an operation to fix this aneurysm.

There are some reasons why you couldn't join. For example, if you can't have an MRI scan (perhaps due to certain metal implants), or if your surgery is an emergency rather than planned. Also, pregnant or breastfeeding women, or people who are not part of the national health insurance system, cannot take part. If you have a guardian or carer who makes health decisions for you (a protected adult), you also wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a bulge (aneurysm) in the upper part of your aorta?
Are you already scheduled for surgery to fix this aneurysm?
Can you safely have an MRI scan (no contraindications)?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve having a special type of scan called a Cardiac MRI. This scan will be done before your planned surgery. An MRI uses strong magnets and radio waves to create detailed images of your heart and aorta. It's a non-invasive procedure, meaning nothing enters your body. Apart from this scan, there will be no extra visits or changes to your planned medical care or surgery.

During your scheduled surgery, the surgeons will remove the problematic section of your aorta. A very small piece of this removed tissue will then be used for laboratory tests to measure its strength and stretchiness. This will happen after the tissue has been removed for your treatment, and won't affect your surgery itself.

There are no additional medications or follow-up appointments specifically for this study. Your participation simply involves the MRI scan and the use of a tissue sample from your surgery. The total duration of your direct involvement would be around the time of your pre-surgery MRI scan.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information gained could help doctors better understand and treat future patients with similar conditions. There are minimal risks involved, mainly associated with the MRI scan, such as being in an enclosed space or the strong magnetic field interacting with certain metal implants; however, these are screened for beforehand. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Chu Dijon Bourogne
Verified postcode
Dijon, France· Recruiting

Common questions

What is an ascending aortic aneurysm?

It's a bulge or weak spot in the main artery (aorta) that leaves your heart, specifically in the part that goes upwards.

What is a Cardiac MRI?

It's a special scan that uses magnets and radio waves to take very detailed pictures of your heart and the surrounding blood vessels, like the aorta.

Will my surgery be different if I join the study?

No, your planned surgery will be exactly the same. The study only uses a small piece of tissue after it's already been removed during your operation.

Will I get any extra treatments?

No, this study doesn't involve any extra treatments or changes to your current medical care plan.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care in any way.

How to find out more

Comlan BLITTI

comlanmawuko.blitti@chu-dijon.fr +33 3 80 29 33 52 Official trial record

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