Pathogenesis and Mechanisms of Mitral Annular Calcification

July 22, 2024 updated by: Amir Lerman, Mayo Clinic
Researchers are testing blood or mitral valve tissue to better understand the reasons why Mitral Annular Calcification (MAC) develops in patients with heart disease.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects referred to the Mayo Clinic valve clinic, with or without MAC. Also, subjects undergoing surgery, either standard surgical MVR or trans-atrial TMVR.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic markers of calcific cardiac valves
Time Frame: Baseline
Measured by Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) in Mitral Annular Calcification (MAC)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Amir Lerman, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2020

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-011417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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