Pathogenesis and Mechanisms of Mitral Annular Calcification | NCT04286009

Studies
Pathogenesis and Mechanisms of Mitral Annular Calcification

NCT04286009

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Jul 23, 2024Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Mitral Annulus Calcification

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2020Actual

Primary Completion Date

Apr 1, 2024Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Feb 25, 2020

First Submission Date that Met QC Criteria

Feb 25, 2020

First Posted Date

Feb 26, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2024

Last Update Posted Date

Jul 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amir Lerman, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided