Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

Sponsor

Creighton University (Other)

Overall Status

Terminated

CT.gov ID

NCT01442467

Collaborator

(none)

Enrollment

Location

19.1

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mitral Annulus Calcification

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Correlation Between Echocardiographic Indices of Diastolic Function (E/E') and Left Ventricular End Diastolic Pressure (LVEDP) in Patients With Mitral Annular Calcification

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Mild to Severe MAC
No to mild MAC

Outcome Measures

Primary Outcome Measures

Agreement between invasive and non-invasive measures of LVEDP [participants will be followed for the duration of hospital stay, an expected average of 2 days]
evaluate the agreement between the E/E' ratio by echocardiography and the left ventricular end-diastolic pressure by cardiac catheterization in patients with moderate to severe mitral annular calcification