Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-25 @ 8:38 AM
Study NCT ID:
NCT02202902
Status:
UNKNOWN
Last Update Posted:
2016-09-29
First Post:
2014-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Steatosis in Cushing's Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003480', 'term': 'Cushing Syndrome'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007854', 'term': 'Lead'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D000098432', 'term': 'Detection Algorithms'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011320', 'term': 'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-28', 'studyFirstSubmitDate': '2014-07-25', 'studyFirstSubmitQcDate': '2014-07-28', 'lastUpdatePostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio', 'timeFrame': 'Assessed twice in patients - before and 6 months after treatment - and once in volunteers', 'description': 'Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy'}], 'secondaryOutcomes': [{'measure': 'Left Ventricular intramyocardial fatt fraction (Dixon)', 'timeFrame': 'Assessed twice in patients - before and 6 months after treatment - and once in volunteers', 'description': 'In/Out of Phase Imaging (Dixon)'}, {'measure': 'Subcutaneous and visceral abdominal fatt', 'timeFrame': 'Assessed twice in patients - before and 6 months after treatment - and once in volunteers', 'description': 'ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level'}, {'measure': 'Cardiac morphology and function', 'timeFrame': 'Assessed twice in patients - before and 6 months after treatment - and once in volunteers', 'description': 'LV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Cushing's syndrome", 'cardiac steatosis', 'intramyocardial triglyceride content', '1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging', 'Left Ventricularly hypertrophy'], 'conditions': ['Endocrine System Disease', 'Cardiovascular Imaging']}, 'referencesModule': {'references': [{'pmid': '34333603', 'type': 'DERIVED', 'citation': 'Wolf P, Marty B, Bouazizi K, Kachenoura N, Piedvache C, Blanchard A, Salenave S, Prigent M, Jublanc C, Ajzenberg C, Droumaguet C, Young J, Lecoq AL, Kuhn E, Agostini H, Trabado S, Carlier PG, Feve B, Redheuil A, Chanson P, Kamenicky P. Epicardial and Pericardial Adiposity Without Myocardial Steatosis in Cushing Syndrome. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3505-3514. doi: 10.1210/clinem/dgab556.'}]}, 'descriptionModule': {'briefSummary': "This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.", 'detailedDescription': "Despite skeletal muscle atrophy, Cushing's syndrome patients have an increased Left Ventricular mass, reversible upon correction of the hypercortisolism. This may be due to cardiac steatosis, previously demonstrated in patients with diabetes mellitus. This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging (CMRI), in patients with Cushing's syndrome and in age-, sex- and BMI-matched healthy volunteers. The patients will be stratified into two groups in function of the presence or absence of diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after efficient treatment of Cushing's syndrome. We make the hypothesis that Cushing's syndrome patients compared to healthy subjects have excess lipid storage in cardiac myocytes irrespectively of the glucose homeostasis status, and that this lipid content will decrease after the correction of hypercortisolism."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* group 1 and 2: patients with overt Cushing's syndrome, with 24-hour urinary free cortisol excretion over the two fold of the upper limit of the normal, with (group 1) or without (group 2) diabetes mellitus or glucose intolerance\n* group 3: healthy volunteers matched for age, sex and BMI with the patients of the group 2\n\nExclusion Criteria:\n\n* contraindication of MRI\n* hypersensitivity to gadolinium\n* acute myocardial ischemia\n* renal insufficiency (creatinin clearance 30 mL/min/l,73m2)\n* pregnancy"}, 'identificationModule': {'nctId': 'NCT02202902', 'acronym': 'CORTICOEUR', 'briefTitle': "Cardiac Steatosis in Cushing's Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study", 'orgStudyIdInfo': {'id': 'AOR12017'}, 'secondaryIdInfos': [{'id': '2013-A01023-42', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 : 1H magnetic resonance spectroscopy and CMRI', 'description': "Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance", 'interventionNames': ['Other: 1H magnetic resonance spectroscopy and CMRI']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 : 1H magnetic resonance spectroscopy and CMRI', 'description': "Group 2: Cushing's syndrome patients with normal glucose intolerance", 'interventionNames': ['Other: 1H magnetic resonance spectroscopy and CMRI']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 : 1H magnetic resonance spectroscopy and CMRI', 'description': 'age-, sex- and BMI-matched healthy volunteers', 'interventionNames': ['Other: 1H magnetic resonance spectroscopy and CMRI']}], 'interventions': [{'name': '1H magnetic resonance spectroscopy and CMRI', 'type': 'OTHER', 'otherNames': ['Before and after Treatment'], 'description': 'Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment', 'armGroupLabels': ['Group 1 : 1H magnetic resonance spectroscopy and CMRI', 'Group 2 : 1H magnetic resonance spectroscopy and CMRI']}, {'name': '1H magnetic resonance spectroscopy and CMRI', 'type': 'OTHER', 'otherNames': ['Once'], 'description': 'Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before treatment', 'armGroupLabels': ['Group 3 : 1H magnetic resonance spectroscopy and CMRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Peter KAMENICKY, MD', 'role': 'CONTACT', 'email': 'peter.kamenicky@bct.aphp.fr', 'phone': '+33 (0)1 45 21 37 06'}], 'facility': 'AP-HP, Bicêtre Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}], 'centralContacts': [{'name': 'Philippe CHANSON, MD, PhD', 'role': 'CONTACT', 'email': 'philippe.chanson@bct.aphp.fr', 'phone': '+33 (0)1 45 21 37 05'}, {'name': 'Peter KAMENICKY, MD', 'role': 'CONTACT', 'email': 'peter.kamenicky@bct.aphp.fr', 'phone': '+33 (0)1 45 21 37 06'}], 'overallOfficials': [{'name': 'Philippe CHANSON, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP, Bicêtre Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}