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Compares treatment options for Ascending Aortic Aneurysm Enlargement
Official title Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
ClinicalTrials.gov ID: NCT03536312
What this study is testing
- What it's testing
- The ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join if
- Patients between the age of 18 and 79 inclusive.
- Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast.
- 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...
You likely can't join if
- Patients who refused to be assigned by chance
- Patients with symptomatic attributable to ascending aortic aneurysms
- Patients who are unable to provide informed consents
- Patients who are unable to attend for regular follow-up/ remain compliant with protocol
- Previous cardiac surgery
- Patients whose primary indication for cardiac surgery is non-AsAA related
See the full eligibility criteria
- Patients between the age of 18 and 79 inclusive.
- Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast.
- 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.
- Patients who refused to be assigned by chance
- Patients with symptomatic attributable to ascending aortic aneurysms
- Patients who are unable to provide informed consents
- Patients who are unable to attend for regular follow-up/ remain compliant with protocol
- Previous cardiac surgery
- Patients whose primary indication for cardiac surgery is non-AsAA related
- Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years
- Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery)
- Ascending aortic and arch aneurysm with descending thoracic aorta involvement
- Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.)
- Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
- Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.)
- Female patients who are pregnant or planning to become pregnant
- 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Ridgewood, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
- Plano, Texas, United States
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Saint John, New Brunswick, Canada
- Halifax, Nova Scotia, Canada
- Greater Sudbury, Ontario, Canada
- Hamilton, Ontario, Canada
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States; St Louis, Missouri, United States; Ridgewood, New Jersey, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.