Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis

Recruiting

• Conditions: Aortic Stenosis; Aortic Valve Disease; Aortic Valve Calcification

• Registration Number: NCT06136689
• Lead Sponsor: Medical University of Warsaw

Brief Summary

The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-14
• Last Update Submitted: 2023-11-14
• Study First Posted: 2023-11-18
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team
• pre-surgical computed tomography angiography
• informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aortic valve tissue composition measured from pre-procedural computed tomography angiography	up to 30-days before surgery	Quantitative analysis of aortic valve composition will be based on pre-surgical planning CTA images using semi-automated software (Autoplaque version 2.5, Cedars-Sinai Medical Center, Los Angeles, CA, USA) for calcified, non-calcified and total tissue volumes.
Aortic valve tissue composition measured from quantitative histology	immediately post-surgery	Different stains will be used to characterize composition of excised aortic valves (hematoxylin and eosin, Movat Pentachrome, Van Gieson's trichrome, Congo Red, anti-CD68 antibody

Trial Locations

Locations (2)

Medical University of Silesia; 🇵🇱 Katowice, Poland

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland