Mitral Annulus CalcificationNCT04093973
Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification
An observational study of Mitral Annulus Calcification, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Many people develop calcium deposits in the heart as they get older. One of the common places for this to occur is the mitral annulus, the band of tissue that supports the mitral valve (one of four heart valves). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Annulus Calcification
- What is being tested?
- bicycle stress echocardiography
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2014to 30 Jun 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: No vulnerable or special populations will be recruited for this study. In particular, those unable to or unwilling to consent, not yet adults, pregnant women and prisoners will be excluded.
Who may be able to join
- At least moderate mitral annular calcification as judged by a previously published semi-quantitative echocardiographic score
- Over 18 years of age
- Able to use the semi-supine exercise bicycle
- Should be able to give informed consent.
Who cannot join
- Oxygen dependent lung or cardiac disease
- Moderate or greater aortic valvular disease
- Moderate or greater mitral regurgitation
- Reduced left ventricular ejection fraction, <35%
- Any diagnosed coronary disease
- A resting mean gradient of ≥10 mmHg across the mitral valve.
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Many people develop calcium deposits in the heart as they get older. One of the common places for this to occur is the mitral annulus, the band of tissue that supports the mitral valve (one of four heart valves). The purpose of this study is to examine effects of these deposits (termed mitral annular calcification or "MAC") on a person's ability to perform exercise. The research team will use ultrasound of the heart (Doppler echocardiography) to study people with MAC while they exercise on a specially designed bicycle.
Read the detailed description
Mitral annular calcification (MAC) involves build-up of calcium in the mitral annulus, the fibro-muscular band which supports the mitral valve. The annulus aids in valve function, contracting in early systole (contraction phase) and bringing the valve leaflets together. In diastole (filling phase) it enlarges allowing blood to flow freely across the valve. Calcification stiffens the annulus and can extend onto the valve leaflets stiffening them. When severe, MAC impairs flow across the valve (mitral stenosis). This is characterized by a pressure gradient across the valve which can be detected by Doppler echocardiography (ultrasound).
Routine Doppler echocardiography is performed at rest when heart rates and flow across the mitral valve are low. Thus, even with severe MAC, there may only be a small pressure gradient present. However, with exercise these gradients can rise rapidly, leading to symptoms such as fatigue and shortness of breath.
MAC is associated with aging and is becoming more prevalent. Our hypothesis is that MAC is a common cause of shortness of breath with exertion. Further, the investigator believes this is under-appreciated because routine Doppler echocardiograms are done at rest. Therefore, the investigator will study adult subjects with moderate to severe MAC during bicycle exercise. Doppler echocardiography will be used to measure both the resting gradient across the mitral valve and changes with exercise. Symptoms will be measured by Borg Perceived Exertion scale.
If the research team is successful, the research team expects to demonstrate convincingly that this commonly encountered finding on Doppler echocardiography is an important cause of patient symptoms.
- Conditions
- Mitral Annulus Calcification
- Being tested
- bicycle stress echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bicycle stress echocardiographyDiagnostic test
Study subjects will perform supine bicycle exercise with echocardiography performed before, during, and after exercise. Definity (perflutren microbubble contrast agent) will be used as needed to enhance echo images.
| Study group | Role | What they receive |
|---|---|---|
| MAC subjects | Outpatients with moderate to severe mitral annular calcification on echocardiogram who are able to perform supine bicycle exercise. Receives: Diagnostic Test: bicycle stress echocardiography | |
| Controls | Sex matched individuals who are within 5 years of age of the paired MAC subject and who have the same left ventricular wall thickness as measured by echocardiography. Receives: Diagnostic Test: bicycle stress echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean mitral valve gradient from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.
Measuring how the pressure gradient across the mitral valve changes during exercise, and comparing these changes between subjects and controls.
Measured: Procedure day
Secondary outcomes (2)
Change in pulmonary artery systolic pressure from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.
Measuring how the blood pressure in the lungs changes during exercise, and comparing these changes between subjects and controls.
Measured: Procedure day
Borg Perceived Exertion Score at peak exercise in patients with Mitral Annular Calcification compared to controls.
Comparing perceived exertion during exercise between subjects and controls. The Borg Scale of Perceived Exertion takes into account an individual's fitness level: It matches how hard a subject feels he/she is working, using numbers from 6 to 20; thus, it is a "relative" scale. The scale starts with "no feeling of exertion," which rates a 6, and ends with "very, very hard," which rates a 20. Moderate activities register 11 to 14 on the Borg scale ("fairly light" to "somewhat hard"), while vigorous activities usually rate a 15 or higher ("hard" to "very, very hard").
Measured: Procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start7 Nov 2014
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Principal investigator, Gregg Pressman, Albert Einstein Healthcare Network
- Investigators
- Gregg S Pressman, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093973
- Sponsor's protocol ID
- HN:4649
- Status last verified
- May 2023
- First submitted
- 17 May 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification
- ClinicalTrials.gov ID
- NCT04093973
- Acronym / sponsor ID
- HN:4649
- Conditions
- Mitral Annulus Calcification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Sep 2019 (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.
Many people develop calcium deposits in the heart as they get older. One of the common places for this to occur is the mitral annulus, the band of tissue that supports the mitral valve (one of four heart valves). The purpose of this study is to examine effects of these deposits (termed mitral annular calcification or "MAC") on a person's ability to perform exercise. The research team will use ultrasound of the heart (Doppler echocardiography) to study people with MAC while they exercise on a specially designed bicycle.
Detailed description
Mitral annular calcification (MAC) involves build-up of calcium in the mitral annulus, the fibro-muscular band which supports the mitral valve. The annulus aids in valve function, contracting in early systole (contraction phase) and bringing the valve leaflets together. In diastole (filling phase) it enlarges allowing blood to flow freely across the valve. Calcification stiffens the annulus and can extend onto the valve leaflets stiffening them. When severe, MAC impairs flow across the valve (mitral stenosis). This is characterized by a pressure gradient across the valve which can be detected by Doppler echocardiography (ultrasound).
Routine Doppler echocardiography is performed at rest when heart rates and flow across the mitral valve are low. Thus, even with severe MAC, there may only be a small pressure gradient present. However, with exercise these gradients can rise rapidly, leading to symptoms such as fatigue and shortness of breath.
MAC is associated with aging and is becoming more prevalent. Our hypothesis is that MAC is a common cause of shortness of breath with exertion. Further, the investigator believes this is under-appreciated because routine Doppler echocardiograms are done at rest. Therefore, the investigator will study adult subjects with moderate to severe MAC during bicycle exercise. Doppler echocardiography will be used to measure both the resting gradient across the mitral valve and changes with exercise. Symptoms will be measured by Borg Perceived Exertion scale.
If the research team is successful, the research team expects to demonstrate convincingly that this commonly encountered finding on Doppler echocardiography is an important cause of patient symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAC subjects | – | Diagnostic Test: bicycle stress echocardiographyOutpatients with moderate to severe mitral annular calcification on echocardiogram who are able to perform supine bicycle exercise. |
| Controls | – | Diagnostic Test: bicycle stress echocardiographySex matched individuals who are within 5 years of age of the paired MAC subject and who have the same left ventricular wall thickness as measured by echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- No vulnerable or special populations will be recruited for this study. In particular, those unable to or unwilling to consent, not yet adults, pregnant women and prisoners will be excluded.
Key inclusion criteria (4 listed)
- At least moderate mitral annular calcification as judged by a previously published semi-quantitative echocardiographic score
- Over 18 years of age
- Able to use the semi-supine exercise bicycle
- Should be able to give informed consent.
Key exclusion criteria (6 listed)
- Oxygen dependent lung or cardiac disease
- Moderate or greater aortic valvular disease
- Moderate or greater mitral regurgitation
- Reduced left ventricular ejection fraction, <35%
- Any diagnosed coronary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bicycle stress echocardiographyStudy subjects will perform supine bicycle exercise with echocardiography performed before, during, and after exercise. Definity (perflutren microbubble contrast agent) will be used as needed to enhance echo images. | Diagnostic test | Controls, MAC subjects |
Primary outcome
Change in mean mitral valve gradient from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.
Time frame: Procedure day
Measuring how the pressure gradient across the mitral valve changes during exercise, and comparing these changes between subjects and controls.
2 secondary outcomes
Change in pulmonary artery systolic pressure from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.
Time frame: Procedure day
Borg Perceived Exertion Score at peak exercise in patients with Mitral Annular Calcification compared to controls.
Time frame: Procedure day
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 24 May 2023.
- Individual participant dataSharing planned: No
Related trials for Mitral Annulus Calcification
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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.
Gregg S Pressman, MD principal investigator
Albert Einstein Healthcare Network
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 Albert Einstein Healthcare Network 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 4 inclusion and 6 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 24 May 2023. 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?
Change in mean mitral valve gradient from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls. (time frame: Procedure day). 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 24 May 2023.