Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 8:11 PM
Study NCT ID:
NCT00810550
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2008-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Ultrasound in the Evaluation of Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2008-12-17', 'studyFirstSubmitQcDate': '2008-12-17', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy for severe CAD', 'timeFrame': '1 Day'}], 'secondaryOutcomes': [{'measure': 'Diagnostic accuracy for significant CAD', 'timeFrame': '1 Day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Cardiomyopathy', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '20569720', 'type': 'DERIVED', 'citation': 'Reynolds HR, Steckman DA, Tunick PA, Kronzon I, Lobach I, Rosenzweig BP. Normal intima-media thickness on carotid ultrasound reliably excludes an ischemic cause of cardiomyopathy. Am Heart J. 2010 Jun;159(6):1059-66. doi: 10.1016/j.ahj.2010.03.026.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.', 'detailedDescription': 'Coronary artery disease (CAD, cholesterol plaque buildup in the heart arteries) is the most common cause of left ventricular systolic dysfunction (weakening of the heart muscle). The standard test to find coronary artery disease is coronary angiography. This test is highly accurate but is invasive and carries a small risk of complications. This study investigates ultrasound of the carotid (neck) arteries as a screening test for severe coronary artery disease as a cause of left ventricular systolic dysfunction. It is hypothesized that carotid ultrasound will have excellent negative predictive value for severe CAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LVEF 40% or less\n\nExclusion Criteria:\n\n* Prior diagnosis of coronary or carotid obstructive atherosclerosis'}, 'identificationModule': {'nctId': 'NCT00810550', 'acronym': 'CUE-HF', 'briefTitle': 'Carotid Ultrasound in the Evaluation of Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Carotid Ultrasound in the Evaluation of Heart Failure', 'orgStudyIdInfo': {'id': 'NYCC CUE-HF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'LV systolic dysfunction', 'description': 'Diagnostic Testing', 'interventionNames': ['Other: Carotid ultrasound']}], 'interventions': [{'name': 'Carotid ultrasound', 'type': 'OTHER', 'description': 'Measurement of intima-media thickness', 'armGroupLabels': ['LV systolic dysfunction']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Harmony R. Reynolds', 'investigatorAffiliation': 'NYU Langone Health'}}}}