Treatment In Thoracic Aortic Aneurysm: Surgery vs. Surveillance (TITAN: SvS)
Aneurysm | ThoracicSome people's ascending aorta (As.A) can become enlarged, increasing the risk of tearing/rupture. This can be highly fatal, despite surgical intervention. The size of aorta where surgical vs surveillance recommendations are grey is between 5.0 to 5.4 cm.
In this trial, patients with a 5.0 to 5.4 cm As.A, will be randomly assigned to either early surgical intervention or the surveillance group.
Results of this trial will guide future practice for patients with enlarged AS.A, specifically the 5.0-5.4 cm size, since the guidance on how to manage this group of patients is not concrete.
Enrolling in a registry is also an option if one does not want to participate in the main randomized trial.
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Conditions de participation
-
Sexe:
Any -
Âges admissibles:
18 to 79
Critères de participation
Inclusion Criteria:
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 clinically monitored with serial CTs, and will be considered for enrollment into the trial once the aneurysm reaches 5.0 cm.
Exclusion Criteria:
Exclusion Criteria:
1) Patients who refused to be randomized (these patients can enroll in the study registry)
2) Patients who are symptomatic, attributable to ascending aortic aneurysms
3) Previous cardiac surgery
4) Patients whose primary indication for cardiac surgery is non-AsAA related
5) Ascending aortic and arch aneurysm with descending thoracic aorta involvement
6) Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.
7) Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
8) Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include: Severe pulmonary disease; Severe kidney disease; 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)
Lieu de l'étude
University of Calgary
University of CalgaryCalgary, Alberta
Canada
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Health Sciences North
Health Sciences NorthGreater Sudbury, Ontario
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Institut universitaire de cardiologie et de pneumologie de Québec
Institut universitaire de cardiologie et de pneumologie de QuébecQuébec, Quebec
Canada
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Horizon Health Network
Horizon Health NetworkSaint John, New Brunswick
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Montreal Heart Institute
Montreal Heart InstituteMontreal, Quebec
Canada
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Nova Scotia Health Authority
Nova Scotia Health AuthorityHalifax, Nova Scotia
Canada
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University of Ottawa Heart Institute
University of Ottawa Heart InstituteOttawa, Ontario
Canada
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McGill University Health Centre
McGill University Health CentreMontreal, Quebec
Canada
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Mazankowski Alberta Heart Institute
Mazankowski Alberta Heart InstituteEdmonton, Alberta
Canada
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Hamilton General Hospital
Hamilton General HospitalHamilton, Ontario
Canada
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Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
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University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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- Étude parrainée par
- Ottawa Heart Institute Research Corporation
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT03536312