Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-03-05 @ 2:32 PM
Study NCT ID:
NCT01442467
Status:
TERMINATED
Last Update Posted:
2013-04-01
First Post:
2011-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Subject accrual too difficult', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between invasive and non-invasive measures of LVEDP', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 days', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mitral annular calcification', 'MAC', 'left atrial pressure', 'LAP', 'left ventricular end diastolic pressure', 'LVEDP', 'Echocardiogram'], 'conditions': ['Mitral Annulus Calcification']}, 'descriptionModule': {'briefSummary': '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.\n\nEchocardiography 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.\n\nCalcification (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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'elective/planned cardiac catheterization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 19 years of age\n* undergoing planned cardiac catheterization\n\nExclusion Criteria:\n\n* \\< 19 years of age\n* acute coronary syndrome\n* decompensated heart failure\n* not in sinus rhythm\n* \\> mild MR\n* hypertensive urgency/emergency\n* severe aortic stenosis\n* poor echo windows for Doppler imaging'}, 'identificationModule': {'nctId': 'NCT01442467', 'briefTitle': 'Study of Echocardiogram Accuracy in Patients With Mitral Valve Calcification', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': "Correlation Between Echocardiographic Indices of Diastolic Function (E/E') and Left Ventricular End Diastolic Pressure (LVEDP) in Patients With Mitral Annular Calcification", 'orgStudyIdInfo': {'id': '11-16085'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild to Severe MAC'}, {'label': 'No to mild MAC'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton Unviversity Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}