Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT04684004
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperglycemia in Patients With Takotsubo Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071459', 'term': 'Death Domain'}], 'ancestors': [{'id': 'D000071458', 'term': 'Death Domain Superfamily'}, {'id': 'D054730', 'term': 'Protein Interaction Domains and Motifs'}, {'id': 'D000072417', 'term': 'Protein Domains'}, {'id': 'D000072416', 'term': 'Protein Structural Elements'}, {'id': 'D011487', 'term': 'Protein Conformation'}, {'id': 'D008968', 'term': 'Molecular Conformation'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of HF events', 'timeFrame': '12 months', 'description': 'To evaluate the number of HF events by clinical visits, telephonic interviews and hospital discharge schedules.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Takotsubo Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '34187841', 'type': 'DERIVED', 'citation': 'Paolisso P, Bergamaschi L, Rambaldi P, Gatta G, Foa A, Angeli F, Fabrizio M, Casella G, Barbieri M, Galie N, Marfella R, Pizzi C, Sardu C. Impact of Admission Hyperglycemia on Heart Failure Events and Mortality in Patients With Takotsubo Syndrome at Long-term Follow-up: Data From HIGH-GLUCOTAKO Investigators. Diabetes Care. 2021 Sep;44(9):2158-2161. doi: 10.2337/dc21-0433. Epub 2021 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be of patients with acute TTC event. The enrolled patients according to inclusion and exclusion criteria will be then divided in normoglycemics vs. hyperglycemics according to blood glucose values at hospital admission.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome;\n* cardiac biomarker modifications (creatine kinase-MB and troponin I);\n* systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV.\n\nExclusion Criteria:\n\n* patients with previous previous myocardial infarction;\n* patients with previous TTC event;\n* patients affected by chronic kidney, liver, and cerebrovascular diseases.'}, 'identificationModule': {'nctId': 'NCT04684004', 'briefTitle': 'Hyperglycemia in Patients With Takotsubo Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up', 'orgStudyIdInfo': {'id': '02.12.20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TTC patients with hyperglycemia', 'description': 'These patients will be hospitalized for TTC acute event. These patients will be characterized by higher blood glucose values at admission, and so defined as hyperglycemics.', 'interventionNames': ['Other: To report number of HF events and deaths']}, {'label': 'TTC patients with normoglycemia', 'description': 'These patients will be hospitalized for TTC acute event. These patients will be characterized by normal blood glucose values at admission, and so defined as normoglycemics.', 'interventionNames': ['Other: To report number of HF events and deaths']}], 'interventions': [{'name': 'To report number of HF events and deaths', 'type': 'OTHER', 'description': 'In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.', 'armGroupLabels': ['TTC patients with hyperglycemia', 'TTC patients with normoglycemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80138', 'city': 'Naples', 'country': 'Italy', 'facility': 'Raffaele Marfella', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Celestino Sardu', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}