Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-30 @ 1:19 AM
Study NCT ID:
NCT00589459
Status:
COMPLETED
Last Update Posted:
2023-08-30
First Post:
2007-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gender Differences in Prevalence of Undiagnosed Diabetes in ACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'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': 'D017202', 'term': 'Myocardial Ischemia'}, {'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_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2008-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2007-12-27', 'studyFirstSubmitQcDate': '2008-01-08', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes', 'timeFrame': 'after hospitalization for acute coronary syndrome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['undiagnosed diabetes', 'undiagnosed pre-diabetes', 'acute coronary syndrome', 'undiagnosed pre-diabetes and undiagnosed diabetes'], 'conditions': ['Pre-diabetes', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women and men admitted with an acute coronary syndrome who do not have a prior diagnosis of diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute coronary syndrome\n* age \\> 30 yrs\n\nExclusion Criteria:\n\n* previously diagnosed diabetes\n* ACS due to substance abuse or trauma'}, 'identificationModule': {'nctId': 'NCT00589459', 'briefTitle': 'Gender Differences in Prevalence of Undiagnosed Diabetes in ACS', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Pilot Study of Gender Differences in the Prevalence of Undiagnosed Diabetes in Acute Coronary Syndromes (ACS)', 'orgStudyIdInfo': {'id': '12258'}, 'secondaryIdInfos': [{'id': 'AHA'}, {'id': "Donaghue Women's Health R02524"}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'non-diabetic women with acute coronary syndrome (ACS)'}, {'label': '2', 'description': 'non-diabetic men with acute coronary syndrome (ACS)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Center for Clinical Investigation', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Barbara I Gulanski, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}, {'name': "Ethel F Donaghue Women's Health Investigator's Program at Yale", 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Barbara I Gulanski, MD, MPH', 'oldOrganization': 'Yale University School of Medicine'}}}}