Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    100
  • sponsor
    Albert Einstein Healthcare Network
Updated on 2 August 2021

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.

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.

Details
Condition Mitral Annulus Calcification
Treatment bicycle stress echocardiography
Clinical Study IdentifierNCT04093973
SponsorAlbert Einstein Healthcare Network
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

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
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