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Pathogenesis and Mechanisms of Mitral Annular Calcification

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04286009
Collaborator
(none)
250
Enrollment
1
Location
29.1
Anticipated Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are testing blood or mitral valve tissue to better understand the reasons why Mitral Annular Calcification (MAC) develops in patients with heart disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim is to test the hypothesis that Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) play a significant role in the process of Mitral Annular Calcification (MAC) as prognostic markers of calcific cardiac valves.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Pathogenesis and Mechanisms of Mitral Annular Calcification
    Actual Study Start Date :
    Jul 28, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Prognostic markers of calcific cardiac valves [Baseline]

      Measured by Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) in Mitral Annular Calcification (MAC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patients with diagnosis of MAC and patients coming to the Valve Clinic without MAC diagnosis Patients who will undergo surgery, either standard surgical MVR or trans-atrial TMVR, with diagnosis of MAC or without diagnosis of MAC
    Exclusion Criteria:
    • Subjects unwilling to participate or to provide consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Amir Lerman, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amir Lerman, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04286009
    Other Study ID Numbers:
    • 19-011417
    First Posted:
    Feb 26, 2020
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Calcinosis

    Study Results

    No Results Posted as of Aug 2, 2022