Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm

NCT05839990 | Completed

• 1 other identifier: Tomsk NRMC aorta
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to analyze the efficacy of the surgical tretment in patients with ascending aortic aneurysm and dilatation. And to assess rate of negative clinical scenarios in non-oparated patients with ascending aortic dilatation

Conditions

Ascending Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• mortality

  assess early and late death cases in aneurysm and dilatation groups in operated and nonoperarted patients

  up to 5 years

• aortic growth

  assess of the aortic growth in mm during foloow up in nonoperated patients

  up to 5 years

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Patients with ascending aortic aneurysm and dlatation who undergo surgical tretment

Procedure: Surgery

Non-surgery

NO INTERVENTION

Patients with ascending aortic dlatation who undergo surveillance

Interventions

Surgery PROCEDURE

Replacement of the ascending aorta in case of anerysm and dilatation

Also known as: Surgical treatment

Surgery

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ascending aortic aneurysm (50 mm and more)
• Ascending aortic dilatation (45-49 mm)

You may not qualify if:

• Aortic dissection
• Patients with known/documented coagulopathy
• Oncological disease (high degrees)
• Severe chronic heart failure
• Refusal of surgical treatment
• Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
• Severe carotid disease, defined as: any patient with previously documented carotid stenosis of \> 70%, without neurological deficits; or carotid stenosis \> 50% with neurological deficits; or previous carotid endarterectomy or stenting
• Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk NRMC

Tomsk, 634012, Russia

Location

MeSH Terms

Conditions

Aneurysm, Ascending Aorta

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Dmitry S Panfilov, PhD, MD

  Cardiology Research Institute, Tomsk National Research Medic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: March 21, 2022
• Primary Completion: March 21, 2022
• Study Completion: August 1, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

RU (1)