Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01442467

Enrollment

Registered

2011-09-28

Start date

2011-06-30

Completion date

2013-01-31

Last updated

2013-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Annulus Calcification

Keywords

mitral annular calcification, MAC, left atrial pressure, LAP, left ventricular end diastolic pressure, LVEDP, Echocardiogram

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results