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

NCT06136689 | Unknown

• 1 other identifier: 1WR/DAR15
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Stenosis; Aortic Valve Disease; Aortic Valve Calcification

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (5)

Severe Aortic Stenosis - High Flow, High Gradient

patients undergoing surgical aortic valve replacement for severe AS

Severe Aortic Stenosis - classical Low Flow, Low Gradient

patients undergoing surgical aortic valve replacement for severe AS

Severe Aortic Stenosis - paradoxical Low Flow, Low Gradient

patients undergoing surgical aortic valve replacement for severe AS

Moderate Aortic Stenosis

patients undergoing aortic root replacement (Bentall procedure)

Heart Transplant

patients undergoing orthotopic heart transplant for any reason

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will involve patients undergoing surgical aortic valve replacement (SAVR) for different phenotypes of severe AS (high-flow high-gradient, classical low-flow low-gradient, and paradoxical low-flow low-gradient) or moderate AS with coexisting aortic aneurysm as part of Bentall procedure. Patients undergoing heart transplant will be considered control group without aortic valve stenosis.

You may qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Polish Cardiac Society: collaborator

Study Sites (2)

Medical University of Silesia

Katowice, Poland

RECRUITING

Poznan University of Medical Sciences

Poznan, Poland

RECRUITING

Related 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.

  PMID: 33247903 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

leaflets of each aortic valve excised at the time of surgery will be separately placed in a pre-filled container with 10% neutral, phosphate-buffered formalin

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve, Calcification of

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Zenon Huczek, MD,PhD

  Medical University of Warsaw

  STUDY DIRECTOR

Central Study Contacts

Kajetan Grodecki, MD, PhD

CONTACT

0048 660675782; kajetan.grodecki@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

PL (2)