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Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

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ClinicalTrials.gov Identifier: NCT01442467
Recruitment Status : Terminated (Subject accrual too difficult)
First Posted : September 28, 2011
Last Update Posted : April 1, 2013
Information provided by (Responsible Party):
Creighton University

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
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 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 : June 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals
U.S. FDA Resources

Mild to Severe MAC
No to mild MAC

Primary Outcome Measures :
  1. Agreement between invasive and non-invasive measures of LVEDP [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
elective/planned cardiac catheterization

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442467

United States, Nebraska
Creighton Unviversity Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01442467     History of Changes
Other Study ID Numbers: 11-16085
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: April 1, 2013
Last Verified: March 2013

Keywords provided by Creighton University:
mitral annular calcification
left atrial pressure
left ventricular end diastolic pressure

Additional relevant MeSH terms:
Calcium Metabolism Disorders
Metabolic Diseases