Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-29 @ 10:07 PM
Study NCT ID:
NCT01047150
Status:
UNKNOWN
Last Update Posted:
2010-01-12
First Post:
2010-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of studies repeated.', 'timeFrame': 'four weeks'}], 'secondaryOutcomes': [{'measure': 'Number of studies that should have been repeated', 'timeFrame': 'two weeks after data collection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial Perfusion Imaging', 'Repeat studies', 'Tetrofosmin', 'Sestamibi'], 'conditions': ['Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'Research Questions:\n\n1. Is there a significant difference between the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi?\n2. Is there a significant difference in the causal repeat rate of myocardial perfusion studies for Tc99m tetrofosmin and Tc99m sestamibi if an independent technologist reviewer blinded to the radiopharmaceutical makes the decision to repeat the study?\n3. Is there a significant difference in the quantitative diagnostic measures reported between the original and the acceptable repeated studies?', 'detailedDescription': 'There are two commonly used Tc-99m based radiopharmaceuticals useful in the diagnosis and localization of regions of reversible myocardial ischemia in the presence or absence of infarction under exercise and rest conditions. One is Tc-99m tetrofosmin (Tc-99m-1,2-bis\\[bis(2-ethoxyethyl) phosphino\\] ethane), the other is Tc-99m sestamibi (Tc-99m- methoxyisobutylisonitrile). When performing a myocardial perfusion SPECT (MPS) study, extracardiac subdiaphragmatic activity adjacent to the myocardium can cause artifacts in the inferior wall and can be detrimental to the accuracy of the study1,2. Following acquisition, MPS studies are routinely checked for potential imaging artifacts. When a separation between the extracardiac activity cannot clearly be distinguished from the myocardium, the study should be repeated. Repeating the SPECT study can affect the efficiency of a lab as well as having a negative influence on patient comfort and overall satisfaction. The goal of this study is to determine if there is a significant difference in the number of studies that should be repeated between the two commonly used radiopharmaceuticals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred for MPI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving sestamibi MPI study or tetrofosmin MPI study\n\nExclusion Criteria:\n\n* Thallium or dual isotope MPI study'}, 'identificationModule': {'nctId': 'NCT01047150', 'briefTitle': 'The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetro and Tc-99m Mibi', 'organization': {'class': 'OTHER', 'fullName': 'Cardiac Imaging of Augusta'}, 'officialTitle': 'The Comparison of the Necessity of Repeat Myocardial Perfusion SPECT Studies Between Tc-99m Tetrofosmin and Tc-99m Sestamibi', 'orgStudyIdInfo': {'id': 'DB1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tetrofosmin Rest patients', 'description': 'Patients that had a Rest myocardial perfusion study using Tc99m tetrofosmin'}, {'label': 'Sestamibi stress patients', 'description': 'Patients that had a stress myocardial perfusion imaging study using Tc99m Sestamibi'}, {'label': 'Tetrofosmin stress patients', 'description': 'Patients that had a stress myocardial perfusion imaging study using Tc99m Tetrofosmin'}, {'label': 'Sestamibi rest patients', 'description': 'Patients that had a rest myocardial perfusion imaging study using Tc99m Sestamibi'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cardiac Imaging of Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'centralContacts': [{'name': 'Danny A Basso, CNMT', 'role': 'CONTACT', 'email': 'dbasso@knology.net', 'phone': '7067243926'}], 'overallOfficials': [{'name': 'Danny A Basso, CNMT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiac Imaging of Augusta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiac Imaging of Augusta', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Gordon Leslie Walters, MD', 'oldOrganization': 'Cardiac Imaging of Augusta'}}}}