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RecruitingNCT04372563Updated Nov 25, 2024

Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.

An observational study in Ascending Aorta Aneurysm and Dilation of the Ascending Aorta, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Recruiting at 2 sites in Russian Federation. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
45 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 80 is below the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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

Inclusion criteria

  1. Extension of the ascending aorta less than 55 mm
  2. Tricuspid Aortic Valves.
  3. Extension of the ascending aorta more than 45 mm

Exclusion criteria

Exclusion Criteria:

  1. Age less 45 years
  2. Age more 75 years
  3. Multiple organ failure
  4. oncological disease
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • healthy

    Healthy patients with normal aortic dimensions

    Other: aortic prosthetics

  • ascending aortic dilation 45-55, operated on

    patients with ascending aortic dilation 45-55, tricuspid aortic valves operated on

    Other: aortic prosthetics

  • ascending aortic dilation 45-55, non operated on

    patients with ascending aortic dilation 45-55, tricuspid aortic valves non operated

    Other: aortic prosthetics

Interventions

  • Otheraortic prosthetics

    aortic prosthetics

06

What researchers measure

Primary outcomes

  1. death

    death

    Time frame: 30 day after operation

  2. aorto-associated complications

    rupture, dissection

    Time frame: 30 day

Secondary outcomes

  1. increasing the diameter of the ascending aorta

    increasing the diameter of the ascending aorta more than 55 mm

    Time frame: 1 year

07

Study locations

1 of 2 sites recruiting
  • Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
    Tomsk, 634012, Russian Federation
    Recruiting
  • Tomsk National Research Medical Center of the Russian Academy of Sciences
    Tomsk, 634012, Russian Federation
    Active, not recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04372563
Lead sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Responsible party
Evgenia V. Lelik (researcher, Tomsk National Research Medical Center of the Russian Academy of Sciences) — Principal investigator
First posted
May 4, 2020
Start date
Jan 24, 2020
Primary completion
Jan 24, 2025 (estimated)
Completion
Jan 24, 2026 (estimated)
Last update
Nov 25, 2024

Study contacts

Boris N Kozlov, MD
Contact
hospital@cardio-tomsk.ru
3822558122
Boris N Kozlov, MD
Contact
eva00@list.ru
89069541331
Evgeniya V Lelik, PhD
principal investigator · Tomsk National Research Medical Center of the Russian Academy of Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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