Treatment for Thoracic Aortic Aneurysms and Valve Conditions
Official title: Clinical Study of Diagnosis and Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Run by Tomsk National Research Medical Center of the Russian Academy of Sciences · NCT04372563 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 45 Years to 75 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences Academic / other |
| Locations | 2 sites (Tomsk and 1 other locations) |
| Status | Recruiting |
| Started | January 24, 2020 |
| Main results expected | January 24, 2025 |
| Study ends | January 24, 2026 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT04372563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is focused on expanding surgical indications, similar studies have shown success in refining treatment criteria for aortic conditions.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: hospital@cardio-tomsk.ru
- Phone: 3822558122
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing surgery and monitoring for ascending aortic aneurysms
This study tests whether early surgery or careful monitoring is better for people aged 18 to 79 with asymptomatic ascending aortic aneurysms that are between 5.0 cm and 5.4 cm.
-
Evaluation of a new valved graft for heart surgery
This study is testing a new heart valve graft in patients having heart surgery to see how well it works and if it's safe.
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Retreatment with the Nectero EAST System for abdominal aortic aneurysm
This will try retreatment with the Nectero EAST System to repair infrarenal abdominal aortic aneurysms in adults who previously received the device under the initial protocol.
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Lipid and mitochondrial clues in aortic aneurysm with bicuspid or tricuspid valves
This study tests whether inflammatory and metabolic signatures in myeloid cells and aortic tissue differ between patients with bicuspid versus tricuspid aortic valves who need surgery for ascending aortic aneurysm.
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Full sternotomy versus J-shaped mini-sternotomy for hemiarch repair of the ascending aorta
This compares outcomes of full sternotomy and J-shaped mini-sternotomy in adults having hemiarch repair for an ascending aortic aneurysm to see which approach leads to better early and late recovery.
-
Using lung ultrasound to improve outcomes in cardiac surgery patients
This study is testing if using lung ultrasound can help doctors find lung problems earlier in patients after heart surgery compared to regular X-rays and CT scans.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.