Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification

This study has been terminated.
(Subject accrual too difficult)
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01442467
First received: August 8, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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
Mitral Annulus Calcification

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Enrollment: 4
Study Start Date: June 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mild to Severe MAC
No to mild MAC

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

elective/planned cardiac catheterization

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442467

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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01442467     History of Changes
Other Study ID Numbers: 11-16085
Study First Received: August 8, 2011
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
mitral annular calcification
MAC
left atrial pressure
LAP
left ventricular end diastolic pressure
LVEDP
Echocardiogram

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 16, 2014