Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
Study NCT ID:
NCT00162357
Status:
COMPLETED
Last Update Posted:
2011-04-15
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D023903', 'term': 'Coronary Restenosis'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017256', 'term': 'Technetium Tc 99m Sestamibi'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015609', 'term': 'Organotechnetium Compounds'}, {'id': 'D009942', 'term': 'Organometallic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-14', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging'}], 'secondaryOutcomes': [{'measure': 'Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus'}, {'measure': 'Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up.'}, {'measure': 'Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2', 'Coronary Restenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type II Diabetes on medication \\& angioplasty within the past 6 months.\n\nExclusion Criteria:\n\n* Myocardial infarction or repeat angioplasty with the past 5 months.\n* Unable to perform exercise or pharmacologic stress test.'}, 'identificationModule': {'nctId': 'NCT00162357', 'briefTitle': 'Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lantheus Medical Imaging'}, 'officialTitle': 'Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention', 'orgStudyIdInfo': {'id': 'CARDIOLITE-406'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Technetium Tc99m Sestamibi', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'city': 'Wausau', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.95914, 'lon': -89.63012}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Local Institution', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Qi Zhu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lantheus Medical Imaging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lantheus Medical Imaging', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Qi Zhu, MD Sr. Medical Director', 'oldOrganization': 'Lantheus Medical Imaging'}}}}