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COMP-AS: Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis

Sponsor
Medical University of Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT06136689
Collaborator
Polish Cardiac Society (Other)
55
Enrollment
2
Locations
40
Anticipated Duration (Months)
27.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    55 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    May 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Silesia Katowice Poland
    2 Poznan University of Medical Sciences Poznań Poland

    Sponsors and Collaborators

    • Medical University of Warsaw
    • Polish Cardiac Society

    Investigators

    • Study Director: Zenon Huczek, MD,PhD, Medical University of Warsaw

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kajetan Grodecki, Principal Investigator, Medical University of Warsaw
    ClinicalTrials.gov Identifier:
    NCT06136689
    Other Study ID Numbers:
    • 1WR/DAR15
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aortic Valve Stenosis
    Aortic Valve Disease
    Constriction, Pathologic

    Study Results

    No Results Posted as of Nov 18, 2023