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

May 4, 2023 updated by: Evgenia V. Lelik, Tomsk National Research Medical Center of the Russian Academy of Sciences

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Expanding indications for surgical treatment of patients with borderline values of the ascending aorta

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Boris N Kozlov, MD
  • Phone Number: 89069541331
  • Email: eva00@list.ru

Study Locations

  • Russian Federation
      • Tomsk, Russian Federation, 634012
        • Recruiting
        • Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
        • Contact:
      • Tomsk, Russian Federation, 634012
        • Active, not recruiting
        • Tomsk National Research Medical Center of the Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy
Healthy patients with normal aortic dimensions
Other: aortic prosthetics
aortic prosthetics
ascending aortic dilation 45-55, operated on
patients with ascending aortic dilation 45-55, tricuspid aortic valves operated on
Other: aortic prosthetics
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
aortic prosthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 30 day after operation
death
30 day after operation
aorto-associated complications
Time Frame: 30 day
rupture, dissection
30 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
increasing the diameter of the ascending aorta
Time Frame: 1 year
increasing the diameter of the ascending aorta more than 55 mm
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Evgeniya V Lelik, PhD, Tomsk National Research Medical Center of the Russian Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2020

Primary Completion (Anticipated)

January 24, 2025

Study Completion (Anticipated)

January 24, 2026

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aortic Aneurysm & Dilation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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