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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04286009
Other study ID # 19-011417
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 28, 2020
Est. completion date June 2024

Study information

Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 250
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prognostic markers of calcific cardiac valves Measured by Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) in Mitral Annular Calcification (MAC) Baseline
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Completed NCT04093973 - Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification
Terminated NCT01442467 - Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification N/A

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