Treatment for Thoracic Aortic Aneurysms and Valve Conditions

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

This study is trying to see if surgery is the right choice for patients with slightly enlarged aortas and specific heart valve conditions, to help improve treatment guidelines for thoracic aortic aneurysms.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 45 Years to 75 Years
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Academic / other)
• Locations: 2 sites (Tomsk and 1 other locations)
• Trial ID: NCT04372563 on ClinicalTrials.gov

What this trial studies

This study aims to clarify the indications for surgical correction in patients with borderline expansion of the ascending aorta, specifically focusing on those with tricuspid and bicuspid aortic valves. It involves observational assessments of patients with ascending aorta measurements between 45 mm and 55 mm to determine the appropriateness of surgical intervention. The study will evaluate the outcomes of aortic prosthetics in these patients to expand the criteria for surgical treatment. By analyzing these cases, the study seeks to provide clearer guidelines for managing thoracic aortic aneurysms.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45 to 75 years with an ascending aorta measurement between 45 mm and 55 mm and tricuspid aortic valves.

Not a fit: Patients with multiple organ failure, oncological diseases, or those outside the age range of 45 to 75 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical guidelines and outcomes for patients with borderline ascending aorta conditions.

How similar studies have performed: While this approach is focused on expanding surgical indications, similar studies have shown success in refining treatment criteria for aortic conditions.

Eligibility criteria

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

Where this trial is running

Tomsk and 1 other locations

• Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences — Tomsk, Russia (Recruiting)
• Tomsk National Research Medical Center of the Russian Academy of Sciences — Tomsk, Russia (Active_not_recruiting)

Study contacts

• Principal investigator: Evgeniya V Lelik, PhD — Tomsk National Research Medical Center of the Russian Academy of Sciences
• Study coordinator: Boris N Kozlov, MD

Conditions Ascending Aorta Aneurysm; Dilation of the Ascending Aorta