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

Aortic Stenosis Clinical Trial

— COMP-AS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136689
• Other study ID #: 1WR/DAR15
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Medical University of Warsaw
• Contact: Kajetan Grodecki, MD, PhD
• Phone: 0048 660675782
• Email: kajetan.grodecki[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Calcification
• Aortic Valve Disease
• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
Poland	Medical University of Silesia	Katowice
Poland	Poznan University of Medical Sciences	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Polish Cardiac Society

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Grodecki K, Tamarappoo BK, Huczek Z, Jedrzejczyk S, Cadet S, Kwiecinski J, Rymuza B, Parma R, Olasinska-Wisniewska A, Fijalkowska J, Protasiewicz M, Walczak A, Nowak A, Gocol R, Slomka PJ, Reczuch K, Jagielak D, Grygier M, Wojakowski W, Filipiak KJ, Dey D. Non-calcific aortic tissue quantified from computed tomography angiography improves diagnosis and prognostication of patients referred for transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2021 May 10;22(6):626-635. doi: 10.1093/ehjci/jeaa304. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic valve tissue composition measured from pre-procedural computed tomography angiography	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.	up to 30-days before surgery
Primary	Aortic valve tissue composition measured from quantitative histology	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	immediately post-surgery