Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT00209404
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2005-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044834', 'term': 'iodixanol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'lastUpdateSubmitDate': '2007-10-30', 'studyFirstSubmitDate': '2005-08-18', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean heart rate'}], 'secondaryOutcomes': [{'measure': 'Image quality'}, {'measure': 'Diagnostic quality'}, {'measure': 'Overall diagnostic information'}, {'measure': 'Frequency and intensity of adverse events'}]}, 'conditionsModule': {'keywords': ['MDCT', 'Coronary Artery', 'Heart Rate', 'Image Quality', 'Diagnostic Quality'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Image quality in coronary artery computed tomography is influenced by the heart rate variation during the examination. The purpose of this clinical trial is to investigate the change in heart rate following injection of a contrast medium called Visipaque™ (iodixanol). Image quality and diagnostic quality of the examination will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with low to moderate suspicion of coronary artery disease referred for retrospective electrocardiogram (ECG)-gated multidetector row computed tomography coronary angiography and with a heart rate \\>75 beats per minute (bpm) will be included.\n\nExclusion Criteria:\n\n* Subjects who take medications that slow down the heart rate or present cardiac arrhythmia at rest will not be included.'}, 'identificationModule': {'nctId': 'NCT00209404', 'briefTitle': 'Iodixanol in Multidetector-Row Computed Tomography-Coronary Angiography (MDCT-CA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'orgStudyIdInfo': {'id': 'DXV407'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Iodixanol 320 mg I/Ml', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78457', 'city': 'Vélizy-Villacoublay', 'country': 'France', 'facility': 'Amersham Health S.A.', 'geoPoint': {'lat': 48.78198, 'lon': 2.19395}}], 'overallOfficials': [{'name': 'Jean-Paul Antonini', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GE Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}}}}