Purpose of this Study
We are doing this to compare the results of early surgical intervention to medical therapy. We want to know if there is a difference in outcomes for these treatment options. We also want to track the health and progress of people with a large ascending aortic aneurysm (a bulge in the aorta caused by weakening in the artery wall).
Who Can Participate?
Eligibility
Adults ages 18-70 who are diagnosed with an ascending aortic aneurysm.
For more information about who can join this study, please contact the study team at shelly.fincannon@duke.edu.
For more information about who can join this study, please contact the study team at shelly.fincannon@duke.edu.
What is Involved?
There are 2 options for participation in this study:
- You can choose to join a registry; OR
- You can participate in a randomized trial
If you choose to join the registry portion of the study, we will collect information from your medical records related to your surgery to repair your aortic aneurysm. In addition to getting information from your records here, we will also call you or meet with you during your regularly scheduled visits to fill out questionnaires. We will begin collecting this information shortly before your surgery and then for up to 10 years after your surgery.
If you choose to join the randomized trial, you will:
- Get a random assignment (like a coin flip) to 1 of 2 groups
-- One group will be treated with surgery and medication to repair aortic aneurysm
-- The other group will be treated with only medication and will be monitored to track how well the aortic aneurysm is healing
If you are assigned to the surgery group, your doctor will surgically repair your aorta according to standard practices. If you are assigned to the surveillance group (monitoring and medication), you will be followed according to your doctor's routine care. Similar to the registry option, we will also collect medical information before treatment begins and for up to 10 years afterward for people who are assigned to either the surgery or surveillance groups.
- You can choose to join a registry; OR
- You can participate in a randomized trial
If you choose to join the registry portion of the study, we will collect information from your medical records related to your surgery to repair your aortic aneurysm. In addition to getting information from your records here, we will also call you or meet with you during your regularly scheduled visits to fill out questionnaires. We will begin collecting this information shortly before your surgery and then for up to 10 years after your surgery.
If you choose to join the randomized trial, you will:
- Get a random assignment (like a coin flip) to 1 of 2 groups
-- One group will be treated with surgery and medication to repair aortic aneurysm
-- The other group will be treated with only medication and will be monitored to track how well the aortic aneurysm is healing
If you are assigned to the surgery group, your doctor will surgically repair your aorta according to standard practices. If you are assigned to the surveillance group (monitoring and medication), you will be followed according to your doctor's routine care. Similar to the registry option, we will also collect medical information before treatment begins and for up to 10 years afterward for people who are assigned to either the surgery or surveillance groups.
Study Details
Full Title
Treatment In Thoracic Aortic Aneurysm: Surgery versus. Surveillance (TITAN: SvS)
Principal Investigator
George
Hughes
Protocol Number
PRO00106128
NCT ID
NCT03536312
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL