RecruitingNAINTERVENTIONAL

Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

This study is about how to best manage an enlarged main artery (ascending aorta) that carries blood from your heart. When this artery, called an aneurysm, gets too big, there's a risk it might tear or burst, which can be very serious. Currently, doctors aren't sure whether it's better to have surgery right away or to watch it closely for certain aneurysm sizes. This study will compare early surgery with careful monitoring for people whose ascending aorta is between 5.0 cm and 5.5 cm. We want to find out which option leads to fewer serious problems like tears, bursts, or death, and ultimately, better health for patients. The results will help doctors decide on the best treatment in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

610

Start

01 Sep 2018

Estimated completion

31 May 2035

Ascending Aortic Aneurysm Enlargement Ascending Aorta Aneurysm

What is this study about?

Your ascending aorta is the largest blood vessel leaving your heart, carrying blood to the rest of your body. Sometimes, this vessel can become enlarged, a condition known as an ascending aortic aneurysm. If it gets too large, there's a serious risk it could tear or burst, which is a life-threatening emergency.

Doctors currently recommend surgery to replace the enlarged section of the aorta if it reaches a certain size, usually around 5.5 cm. However, this recommendation is based on older evidence, and sometimes smaller aneurysms can also cause problems. On the other hand, surgery itself carries risks. So, for people with aneurysms slightly smaller than the usual surgery threshold, doctors aren't entirely sure whether early surgery or careful monitoring is the safest approach.

This study, called TITAN SvS, aims to answer that question. We are looking for people with an ascending aortic aneurysm between 5.0 cm and 5.5 cm. If you join, you would be randomly assigned to one of two groups: either having surgery soon to replace the enlarged part of your aorta, or being carefully monitored with regular check-ups. By comparing what happens in both groups, we hope to learn which option leads to better overall health and fewer serious issues like tears or bursts, helping doctors provide the best care in the future.

Key takeaways

Compares early surgery versus careful monitoring for a specific heart artery problem.
Aims to improve treatment decisions for people with medium-sized ascending aortic aneurysms.
Involves a random assignment to one of two treatment groups.
Careful monitoring and follow-up for at least two years.
Hopes to uncover which approach leads to fewer serious health issues and better quality of life.

Who may be eligible?

This study is looking for adults aged 18 to 79. You would need to have an ascending aortic aneurysm that measures between 5.0 cm and 5.4 cm on a special scan (CT scan).

If your aneurysm is currently between 4.5 cm and 4.9 cm, you might still be able to join later. In this case, doctors would monitor you with regular CT scans, and if your aneurysm grows to 5.0 cm or more, you could then be considered for the study.

There are several reasons why you might not be able to join. For example, if your aneurysm is causing symptoms, if you've had previous heart surgery, or if you have certain other medical conditions (like some genetic conditions or severe kidney disease) or if you are pregnant or planning to become pregnant. You also need to be able to attend all your follow-up appointments. The study team will check all these details carefully to make sure the study is right for you.

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 between 18 and 79 years old?
Has a doctor told you that you have an ascending aortic aneurysm between 5.0 cm and 5.4 cm?
Are you currently not having any symptoms that could be from your aneurysm?
Have you NOT had previous heart surgery?
Are you able to attend regular follow-up appointments?
Are you NOT pregnant or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step involves a full check-up. This includes reviews of your health history and current medications, measurements like your weight and blood pressure, blood tests, and scans like an ECG, chest X-ray, and a CT scan. You’ll also fill out a questionnaire about your quality of life.

If you fit the criteria, you would then be randomly placed into one of two groups. If you're in the 'early surgery' group, your operation to replace the aorta would usually be scheduled within 10-12 weeks. During this time, you would receive medication to help manage your aneurysm and blood pressure. The specific type of surgery would be decided by your surgeon. If you're in the 'monitoring' group, you would have regular check-ups and scans to keep an eye on your aneurysm.

Everyone in the study will be followed for at least two years to see how they are doing. Throughout the study, doctors will collect information about your health, any major problems, and your quality of life. You will have regular appointments and tests as part of your group's plan.

Potential risks and benefits

Taking part in this study could help us learn what the best treatment is for people with your condition, which may benefit future patients. For you, if you are in the surgery group, there are the potential benefits and risks associated with major heart surgery. If you are in the monitoring group, there is the potential benefit of avoiding surgery, but also the potential risk that your aneurysm could worsen while being watched. You will receive very careful monitoring in both groups. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (28)

University of California at San Francisco Medical Center
Verified postcode
San Francisco, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
University of Michigan
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Ann Arbor, United States· Recruiting
Mayo Clinic
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Rochester, United States· Recruiting
Washington University School of Medicine
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St Louis, United States· Recruiting
The Valley Hospital, Inc
Verified postcode
Ridgewood, United States· Recruiting
Icahn School of Medicine at Mount Sinai
Verified postcode
New York, United States· Recruiting
Duke University
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Durham, United States· Recruiting
University Hospitals Cleveland
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Cleveland, United States· Recruiting
Ohio State University Medical Center
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Columbus, United States· Recruiting
The Trustees of the University of Pennsylvania
Verified postcode
Philadelphia, United States· Recruiting

Common questions

What is an ascending aortic aneurysm?

It's when the largest blood vessel leaving your heart, called the ascending aorta, becomes enlarged or bulges out.

Why is this condition serious?

If the aneurysm gets too big, there's a risk it could tear or burst, which is a life-threatening medical emergency.

What is the main question this study is trying to answer?

The study wants to find out if early surgery or careful monitoring is better for people with a medium-sized ascending aortic aneurysm (5.0-5.5 cm).

Will I get to choose if I have surgery or not?

No, if you join this study, you will be randomly assigned to either the surgery group or the monitoring group, like flipping a coin.

How long will I be in the study?

You'll be followed by the study team for at least two years after you join.

How to find out more

Khatira Mehdiyeva

kmehdiyeva@ottawaheart.ca 613-696-7000 Official trial record

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