Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
NCT ID: NCT03536312
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
610 participants
INTERVENTIONAL
2018-09-01
2035-05-31
Brief Summary
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This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.
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Detailed Description
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When the patient is first assessed in clinic, a pre-randomization evaluation will be completed. Baseline information of the patient, including demographics, past medical history, family history, medications, smoking habits, and the characteristics of the aneurysm, is collected. Measurements including weight, height, heart rate, blood pressure in both arms, is recorded. Basic blood work, including hemoglobin, white cell count, platelets, electrolytes, creatinine, random blood sugar, HbA1c, and cholesterol profile is taken for analysis. An electrocardiograph, chest X-ray, and a CT scan from the surgeon's institution is also obtained. SF-36, the quality of life questionnaire, will be completed by the patient. Those patients that are suitable for the trial based on inclusion and exclusion criteria will then be randomized en-site through a computer-generated randomization program.
For the patients randomized to elective surgery group, the surgery is scheduled within 10-12 weeks of randomization. In the interim, the patient will be placed on maximal medical therapy for their aneurysm, including beta-blocker, statin, and blood pressure control, and the doses of these medication will be individualized based on each patient's own physiological response. The types of surgery (ascending aortic replacement, Bentall procedure, valve-sparing root replacement, etc.) will be at the discretion of the surgeon. The details of the surgery and the patient's course of postoperative hospital stay is recorded. The patient will be managed postoperatively according to routine hospital care. After discharge, patients will be seen at 1 months for their routine postoperative follow up, then annually counting from their index clinic visit before the surgery. At the first postoperative clinic visit, weight, height, heart rate, blood pressure in both arms, is recorded. Basic blood work, including hemoglobin, white cell count, platelets, electrolytes, creatinine is taken for analysis. An electrocardiograph and chest X-ray will be obtained. All subsequent clinic visits can be done in person or by phone conducted by a study coordinator. A CT scan will be obtained at all subsequent clinic visits. Mortality status and occurrence of acute aortic event or stroke in the previous year will be assessed at every annual clinic visit. Quality of life assessment by SF-36 questionnaire will be completed by the patient in person or by phone at 1 year and 2 years follow-up. Annual follow-up will continue until either the patient dies or the trial ends. Patients who are randomized to the surveillance group will be placed on maximal medical therapy for their aneurysm, including beta-blocker, statin, and blood pressure control. The doses of these medication will be individualized based on each patient's own physiological response. The patients will undergo a CT scan of the chest at the first clinic visit then annually for the duration of the study. All CTs will be uploaded to a core CT imaging lab where the image will be reviewed by a Radiologist. If the aneurysm grows beyond 5.5 cm or the patient develop symptoms, the surgeon will consider the patient for surgery. At all clinic visits, in addition to CT, weight, height, heart rate, blood pressure in both arms, an electrocardiograph, and a chest X-ray will be obtained. The surveillance visits continue until either the patient dies, the trial ends, or surgery is considered. If the patient is no longer considered a suitable candidate for surgery or refuse surgery, follow-up will continue, and the patient will no longer be a part of the trial and will only be registered in the side arm.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Surveillance Arm
Patients in the Non-Operative Registry will be followed in clinic annually with a CT scan to monitor the status of their ascending aortic aneurysm, until the end of the study, the occurrence of an aortic event, or death.
No interventions assigned to this group
Surgery/Treatment Arm
Patients in the Operative Registry will have thoracic aortic surgery
Thoracic Aortic Surgery
Thoracic aortic surgery to treat thoracic aortic aneurysm
Interventions
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Thoracic Aortic Surgery
Thoracic aortic surgery to treat thoracic aortic aneurysm
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
79 Years
ALL
No
Sponsors
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University of Calgary
OTHER
University Health Network, Toronto
OTHER
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
OTHER
Hamilton General Hospital
UNKNOWN
Montreal Heart Institute
OTHER
University of Pennsylvania
OTHER
Massachusetts General Hospital
OTHER
McGill
UNKNOWN
University of Michigan
OTHER
Ohio State University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Washington University School of Medicine
OTHER
University Hospitals Cleveland Medical Center
OTHER
University of Alberta
OTHER
Mayo Clinic
OTHER
Medical University of South Carolina
OTHER
Nova Scotia Health Authority
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Horizon Health Network
OTHER
The University of Texas Health Science Center, Houston
OTHER
San Francisco Veterans Affairs Medical Center
FED
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Principal Investigators
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Munir Boodhwani, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Jehangir Appoo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of California at San Francisco Medical Center
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
The Valley Hospital, Inc
Ridgewood, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University
Durham, North Carolina, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
MUSC Health University Medical Center
Charleston, South Carolina, United States
University of Texas Health Science Centre
Houston, Texas, United States
Baylor Scott & White Research Institute
Plano, Texas, United States
University of Calgary
Calgary, Alberta, Canada
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
Horizon Health Network
Saint John, New Brunswick, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Nimesh Desai, MD
Role: primary
Philippe Demers, MD
Role: primary
References
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Guo MH, Appoo JJ, Wells GA, Chu M, Ouzounian M, Fortier J, Boodhwani M. Protocol for a randomised controlled trial for Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS). BMJ Open. 2021 May 26;11(5):e052070. doi: 10.1136/bmjopen-2021-052070.
Other Identifiers
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20180007-01H
Identifier Type: -
Identifier Source: org_study_id
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