Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

Mitral Annulus Calcification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01442467
• Other study ID #: 11-16085
• Status: Terminated
• Phase: N/A
• First received: August 8, 2011
• Last updated: March 28, 2013
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Calcinosis
• Mitral Annulus Calcification

Locations

Country	Name	City	State
United States	Creighton Unviversity Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between invasive and non-invasive measures of LVEDP	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	participants will be followed for the duration of hospital stay, an expected average of 2 days	No