Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

NCT ID: NCT01442467

Last Updated: 2013-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

Brief Summary

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This study aims to evaluate the accuracy of the echocardiographic data obtained from patients with calcifications in the mitral valve who are undergoing a cardiac (heart) catheterization.

Echocardiography is a non-invasive (does not break the skin) procedure used to see an image of the heart. It uses harmless sound waves to create an image of the heart on a computer screen. These images will show the valves of the heart, how well the heart is pumping blood, the blood flow across these valves and how large the heart is. A silver paddle-shaped device is moved easily over the skin to capture these images.

Calcification (hardening) of the heart valves and heart rings (fibrous tissue surrounding the valves) is a common finding and it increases with age. The presence of calcification changes the blood flow through the heart valves. This makes any echocardiographic data (information) obtained from patients with calcifications difficult to interpret.

Detailed Description

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Patients with significant mitral annular calcification (MAC) have largely been excluded from studies validating non invasive (echocardiographic) measurements of left ventricular filling and diastolic function. The investigators hypothesize that echocardiographic estimates of diastolic function, left atrial pressure (LAP) and left ventricular end diastolic pressure (LVEDP) are likely to be fallacious in patients with moderate to severe mitral annular calcification due to the structural alterations and technical difficulties involved.

Conditions

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Mitral Annulus Calcification

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild to Severe MAC

No interventions assigned to this group

No to mild MAC

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* \>= 19 years of age
* undergoing planned cardiac catheterization

Exclusion Criteria

* \< 19 years of age
* acute coronary syndrome
* decompensated heart failure
* not in sinus rhythm
* \> mild MR
* hypertensive urgency/emergency
* severe aortic stenosis
* poor echo windows for Doppler imaging
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Creighton Unviversity Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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11-16085

Identifier Type: -

Identifier Source: org_study_id

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