Ascending Aorta AneurysmNCT04372563
Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
An observational study of Ascending Aorta Aneurysm and Dilation of the Ascending Aorta, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 2 sites in Russia.
Trial summary
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ascending Aorta Aneurysm, Dilation of the Ascending Aorta
- What is being tested?
- aortic prosthetics
- How many people
- 80 participants
- Where
- 2 sitesRussia
- Study dates
- 24 Jan 2020to 24 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- Extension of the ascending aorta less than 55 mm
- Tricuspid Aortic Valves.
- Extension of the ascending aorta more than 45 mm
Who cannot join
- Age less 45 years
- Age more 75 years
- Multiple organ failure
- oncological disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia2 sites, 1 recruiting
- Recruiting
Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
Tomsk, 634012
Nikolay O Kamenshchikov, M.D., +7 9138183657, nikolajkamenof@mail.ru
- Active, not recruiting
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, 634012
About this study
Official title: Clinical Study of Diagnosis and Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta
Read the detailed description
Expanding indications for surgical treatment of patients with borderline values of the ascending aorta
- Being tested
- aortic prosthetics
- Medical subject headings
- Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic prostheticsOther
aortic prosthetics
| Study group | Role | What they receive |
|---|---|---|
| healthy | Healthy patients with normal aortic dimensions Receives: Other: aortic prosthetics | |
| ascending aortic dilation 45-55, operated on | patients with ascending aortic dilation 45-55, tricuspid aortic valves operated on Receives: Other: aortic prosthetics | |
| ascending aortic dilation 45-55, non operated on | patients with ascending aortic dilation 45-55, tricuspid aortic valves non operated Receives: Other: aortic prosthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death
Measured: 30 day after operation
aorto-associated complications
rupture, dissection
Measured: 30 day
Secondary outcomes (1)
increasing the diameter of the ascending aorta
increasing the diameter of the ascending aorta more than 55 mm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start24 Jan 2020
- Primary completion24 Jan 2025 (estimated)
- Study completion24 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aorta AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgenia V. Lelik, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Evgeniya V Lelik, PhD, Principal investigator, Tomsk National Research Medical Center of the Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372563
- Sponsor's protocol ID
- Aortic Aneurysm & Dilation
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2020
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Diagnosis and Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
- ClinicalTrials.gov ID
- NCT04372563
- Acronym / sponsor ID
- Aortic Aneurysm & Dilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 24 Jan 2025 (estimated)
- Study completion
- 24 Jan 2026 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta
Detailed description
Expanding indications for surgical treatment of patients with borderline values of the ascending aorta
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy | – | Other: aortic prostheticsHealthy patients with normal aortic dimensions |
| ascending aortic dilation 45-55, operated on | – | Other: aortic prostheticspatients with ascending aortic dilation 45-55, tricuspid aortic valves operated on |
| ascending aortic dilation 45-55, non operated on | – | Other: aortic prostheticspatients with ascending aortic dilation 45-55, tricuspid aortic valves non operated |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- Extension of the ascending aorta less than 55 mm
- Tricuspid Aortic Valves.
- Extension of the ascending aorta more than 45 mm
Key exclusion criteria (4 listed)
- Age less 45 years
- Age more 75 years
- Multiple organ failure
- oncological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aortic prostheticsaortic prosthetics | Other | ascending aortic dilation 45-55, non operated on, ascending aortic dilation 45-55, operated on, healthy |
Primary outcome
death
Time frame: 30 day after operation
death
aorto-associated complications
Time frame: 30 day
rupture, dissection
1 secondary outcome
increasing the diameter of the ascending aorta
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Ascending Aorta Aneurysm
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Aneurysm, Dissection
RecruitingObservational study
A Study of Lipid Metabolism and Mitochondrial Function in Myeloid Cells and Total Aortic Tissue in Patients With Ascending Thoracic Aortic Aneurysm (ATA) and Bicuspid (BA) or Tricuspid (TA) Aortic Valves.
Ascending Aortic Aneurysm
Enrolling by invitation
Evaluation of Visceral Function Following Endovascular Aortic Aneurysm Repair Using Branched Stent- Grafts
Aortic Aneurysm, Abdominal, Ascending Aorta Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evgeniya V Lelik, PhD principal investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascending Aorta Aneurysm and Dilation of the Ascending Aorta, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris N Kozlov, MD (3822558122, hospital@cardio-tomsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 30 day after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.