Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Clinical Study of Diagnosis and Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
1 other identifier
observational
80
1 country
2
Brief Summary
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2020
CompletedFirst Submitted
Initial submission to the registry
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2026
CompletedNovember 25, 2024
November 1, 2024
5 years
April 29, 2020
November 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
death
death
30 day after operation
aorto-associated complications
rupture, dissection
30 day
Secondary Outcomes (1)
increasing the diameter of the ascending aorta
1 year
Study Arms (3)
healthy
Healthy patients with normal aortic dimensions
ascending aortic dilation 45-55, operated on
patients with ascending aortic dilation 45-55, tricuspid aortic valves operated on
ascending aortic dilation 45-55, non operated on
patients with ascending aortic dilation 45-55, tricuspid aortic valves non operated
Interventions
aortic prosthetics
Eligibility Criteria
Patients with computed tomography-diagnosed ascending aortic dilation greater than 45 mm, less than 55 mm with tricuspid aortic valve compared to patients with bicuspid aortic valve and healthy volunteers
You may qualify if:
- Extension of the ascending aorta less than 55 mm
- Tricuspid Aortic Valves.
- Extension of the ascending aorta more than 45 mm
You may not qualify if:
- Age less 45 years
- Age more 75 years
- Multiple organ failure
- oncological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, 634012, Russia
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, 634012, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeniya V Lelik, PhD
Tomsk National Research Medical Center of the Russian Academy of Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- researcher
Study Record Dates
First Submitted
April 29, 2020
First Posted
May 4, 2020
Study Start
January 24, 2020
Primary Completion
January 24, 2025
Study Completion
January 24, 2026
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share