Mitral Annulus CalcificationNCT04286009
Pathogenesis and Mechanisms of Mitral Annular Calcification
An observational study of Mitral Annulus Calcification, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mitral Annulus Calcification
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2020to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Subjects unwilling to participate or to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Researchers are testing blood or mitral valve tissue to better understand the reasons why Mitral Annular Calcification (MAC) develops in patients with heart disease.
Read the 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.
- Conditions
- Mitral Annulus Calcification
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic markers of calcific cardiac valves
Measured by Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) in Mitral Annular Calcification (MAC)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start28 Jul 2020
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Annulus CalcificationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286009
- Sponsor's protocol ID
- 19-011417
- Status last verified
- Jul 2024
- First submitted
- 25 Feb 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogenesis and Mechanisms of Mitral Annular Calcification
- ClinicalTrials.gov ID
- NCT04286009
- Acronym / sponsor ID
- 19-011417
- Conditions
- Mitral Annulus Calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects unwilling to participate or to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic markers of calcific cardiac valves
Time frame: Baseline
Measured by Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) in Mitral Annular Calcification (MAC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Mitral Annulus Calcification
Recruiting
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Mitral Annulus Calcification, Rheumatic Heart Disease
RecruitingObservational study
Abbott Cephea Mitral Valve Disease Registry
Mitral Regurgitation, Mitral Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Lerman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Annulus Calcification, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic markers of calcific cardiac valves (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.