Bicycle Exercise Echocardiography to Assess Physiological Significance of Mitral Annular Calcification

NCT04093973 | Completed FDA Drug

• 1 other identifier: HN:4649
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Annulus Calcification

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Procedure day

• Borg Perceived Exertion Score at peak exercise in patients with Mitral Annular Calcification compared to controls.

  Procedure day

Study Arms (2)

MAC subjects

Outpatients with moderate to severe mitral annular calcification on echocardiogram who are able to perform supine bicycle exercise.

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.

Diagnostic Test: bicycle stress echocardiography

Interventions

bicycle stress echocardiography DIAGNOSTIC_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.

Controls; MAC subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Lantheus Medical Imaging: collaborator

Study Sites (1)

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Study Officials

• Gregg S Pressman, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: September 18, 2019
• Study Start: November 7, 2014
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)