Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification
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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 |
- 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 |
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
Contacts and Locations 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 June 18, 2013