- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442467
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton Unviversity Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Mild to Severe MAC
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No to mild MAC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-16085
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Clinical Trials on Mitral Annulus Calcification
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-
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-
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Suez Canal UniversityNational Research Centre, EgyptCompletedMitral Valve Replacement | Diseases of Mitral Valves | Abnormality of Mitral Valve Annulus (Disorder)Egypt
-
Mayra GuerreroRecruitingMitral Regurgitation | Mitral Valve Disease | Mitral Annular Calcification | Mitral StenosisUnited States
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National and Kapodistrian University of AthensRecruitingAortic Valve Stenosis | Mitral Valve Stenosis | Aortic Valve Calcification | Mitral Annular Calcification | Mitral Valve CalcificationGreece
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Baylor Research InstituteEdwards LifesciencesCompletedMitral Annular CalcificationUnited States
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RWTH Aachen UniversityCompletedCoronary Calcification | Valvular CalcificationGermany
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Ramathibodi HospitalCompletedVascular Calcification | Coronary CalcificationThailand