Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-02-26 @ 7:25 PM
Study NCT ID:
NCT02510703
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2015-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2015-07-27', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of quantitative variables coronary endothelial function in PET according to the presence or absence of type 2 diabetes in patients investigated with the waning of a first heart attack', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.\n\nThe main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a first myocardial infarction, type 2 diabetic or non-diabetic treated by angioplasty in acute phase (TIMI 3)\n* Myocardial viability test before discharge\n* Age over 18 years\n* Informed Consent dated and signed by the patient\n* Written and spoken French\n* Beneficiary of social security insurance\n\nExclusion Criteria:\n\n* Hypertension\\> 160/90 mmHg despite medical treatment\n* Lack of effective revascularization in acute phase of myocardial infarction (TIMI grade \\<3)\n* Significant three-vessel coronary artery disease (\\> 70% stenosis in the other two coronary arteries); occlusion of a coronary artery; schedule revascularization (percutaneous or surgical); left main coronary artery stenosis\n* Previous history of myocardial infarction\n* Mechanical complication (mitral regurgitation, ventricular septal rupture, left ventricular free wall rupture)\n* Heart failure\n* No myocardial viability test before discharge, for whatever reason\n* Type 1 diabetes\n* Pregnant and / or lactating\n* Age under 18 years or guardianship'}, 'identificationModule': {'nctId': 'NCT02510703', 'acronym': 'D-TEP', 'briefTitle': 'Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'orgStudyIdInfo': {'id': '09-085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Type 2 diabetes group', 'description': 'Type 2 diabetes group', 'interventionNames': ['Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)']}, {'type': 'OTHER', 'label': 'no diabetes', 'description': 'no diabetes', 'interventionNames': ['Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)']}], 'interventions': [{'name': 'Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)', 'type': 'OTHER', 'armGroupLabels': ['Type 2 diabetes group', 'no diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Service de Cardiologie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}