Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
Study NCT ID:
NCT02932592
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2016-09-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'CGMS'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'CGMS'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-21', 'studyFirstSubmitDate': '2016-09-30', 'studyFirstSubmitQcDate': '2016-10-11', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic status', 'timeFrame': '15 days', 'description': 'Patients with dysglycemia (not diabetic patients) will be undergone a monitoring of blood glucose with a device till the discharge of the patient.\n\nThen, an oral glucose tolerance test (OGTT) will be done to categorize the patient as having impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or diabetes mellitus.'}], 'secondaryOutcomes': [{'measure': 'Lipid profile', 'timeFrame': '15 days', 'description': 'Total cholesterol'}, {'measure': 'Lipid profile', 'timeFrame': '15 days', 'description': 'HDL-cholesterol'}, {'measure': 'Lipid profile', 'timeFrame': '15 days', 'description': 'Triglycerides'}, {'measure': 'Lipid profile', 'timeFrame': '15 days', 'description': 'Lipoprotein (a)'}, {'measure': 'Endothelial damage', 'timeFrame': '15 days', 'description': 'sICAM-1'}, {'measure': 'Endothelial damage', 'timeFrame': '15 days', 'description': 'sVCAM-1'}, {'measure': 'Inflammation parameters', 'timeFrame': '15 days', 'description': 'sRAGE'}, {'measure': 'Inflammation parameters', 'timeFrame': '15 days', 'description': 'sCD40L'}, {'measure': 'Inflammation parameters', 'timeFrame': '15 days', 'description': 'MPO'}, {'measure': 'Inflammation parameters', 'timeFrame': '15 days', 'description': 'hs-CRP'}, {'measure': 'Inflammation parameters', 'timeFrame': '15 days', 'description': 'IL-6'}, {'measure': 'Inflammation parameters', 'timeFrame': '15 days', 'description': 'TNF-alfa'}, {'measure': 'Heart damage', 'timeFrame': '15 days', 'description': 'CPK'}, {'measure': 'Heart damage', 'timeFrame': '15 days', 'description': 'I troponin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'To evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)', 'detailedDescription': 'All nondiabetic patients with dysglycemia (fasting plasma glucose between 100 and 125 mg/dl) will be monitored with a device (Continuous Glucose Monitoring System) and all these patients will be undergone an oral glucose tolerance test after the discharge from this Unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nondiabetic patients\n* acute coronary syndrome\n\nExclusion Criteria:\n\n* diabetic patients'}, 'identificationModule': {'nctId': 'NCT02932592', 'acronym': 'AGREEMENT', 'briefTitle': 'evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients (AGREEMENT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'evAluation of Glycemic RangE During acutE Coronary syndroME in Nondiabetic paTients', 'orgStudyIdInfo': {'id': '20160000072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dysglycemic group', 'description': 'Patients with dysglycemia (not diabetic patients) will be undergone a monitoring of blood glucose with a device till the discharge of the patient.\n\nThen, an oral glucose tolerance test (OGTT) will be done to categorize the patient as having impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), or diabetes mellitus.', 'interventionNames': ['Device: Continuous Glucose Monitoring System (i Pro 2 - Medtronic)']}], 'interventions': [{'name': 'Continuous Glucose Monitoring System (i Pro 2 - Medtronic)', 'type': 'DEVICE', 'description': 'This device can register blood glucose values and excursions. This device consists of a needle (applied in subcutaneous way) and of a recording device.', 'armGroupLabels': ['Dysglycemic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Giuseppe Derosa', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Giuseppe Derosa, MD, PhD, FESC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FESC', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}