Comparing surgery and monitoring for ascending aortic aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of early surgical intervention versus surveillance in patients with asymptomatic ascending aortic aneurysms measuring between 5.0 cm and 5.4 cm. Patients aged 18 to 79 will be randomly assigned to either undergo surgery or be closely monitored. The study aims to gather data on patient outcomes, including the risk of aneurysm rupture and overall survival rates. Comprehensive baseline assessments will be conducted, including imaging and quality of life evaluations, to ensure appropriate patient selection and monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients between the age of 18 and 79 inclusive.
2. Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast.
3. Patients with ascending aortic aneurysm with a diameter of 4.5 cm - 4.9 cm will be observed with serial CT, and will be considered for enrollment into the trial once the aneurysm reaches 5.0 cm.

Exclusion Criteria:

1. Patients who refused to be randomized
2. Patients with symptomatic attributable to ascending aortic aneurysms
3. Patients who are unable to provide informed consents
4. Patients who are unable to attend for regular follow-up/ remain compliant with protocol
5. Previous cardiac surgery
6. Patients whose primary indication for cardiac surgery is non-AsAA related
7. Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years
8. Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery)
9. Ascending aortic and arch aneurysm with descending thoracic aorta involvement
10. Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.)
11. Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
12. Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.)
13. Female patients who are pregnant or planning to become pregnant
14. Patients who have a history or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would render the subject ineligible for study participation.
15. Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include:

    * Severe pulmonary disease
    * Cr = 250umol/L
    * Child Pugh Class B or C
    * NYHA III or IV
    * MI within the last 6 months
    * Major surgical procedure or angioplasty within 3 months
    * Expected survival less than 5 years because of other disease (e.g. invasive cancer)

Where it's running

• University of California at San Francisco Medical Center
  San Francisco, California, United States Recruiting
• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Munir Boodhwani, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Khatira Mehdiyeva
• Email: kmehdiyeva@ottawaheart.ca
• Phone: 613-696-7000

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.