CompletedNot Applicable

Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification

United States40 participantsStarted 2014-11-07

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in mean mitral valve gradient from baseline to peak exercise in patients with Mitral Annular Calcification compared to controls.

Timeframe: Procedure day

Trial details

NCT IDNCT04093973

SponsorAlbert Einstein Healthcare Network

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Mitral Annulus Calcification trials