Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-10 @ 7:22 AM
Study NCT ID:
NCT02240056
Status:
COMPLETED
Last Update Posted:
2019-03-07
First Post:
2014-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain fMRT In Takotsubo Cardiomyopathy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-12', 'lastUpdatePostDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in brain functional MRT (resting state, paradigma) in postmenopausal females suffering from TTC as compared to NSTEMI / STEMI postmenopausal female patients', 'timeFrame': 'Within the first 72h after diagnosis and after 4-8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Takotsubo Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Certain cardiac and neurologic diseases influence each other via a still poorly understood "brain-heart axis". Subarachnoidal bleedings are well known to cause ECG alterations resembling those of myocardial infarction, along with a reduction of systolic myocardial function ("neurogenic stunned myocardium"). Alterations of the right insula region by a stroke or intracranial hemorrhage go along with a sympathetic activation (increased circulating catecholamine levels, tachycardia, arterial hypertension). In contrast, alterations of the left insula region often cause vagal reactions such as bradycardia, arterial hypotension. Takotsubo cardiomyopathy (TTC) is a just recently recognised subform of heart attacks, often caused by psychological or physical stress (death of a beloved one, divorce, job loss, infection, preoperative state). In more than 90% of cases, TTC affects postmenopausal women.\n\nFunctional MRT enables imaging of activated brain regions, either without ("resting state") or with specific stimuli. The investigators speculate that there is a specific involvement of the insula region during TTC.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women with TTC or NSTEMI / STEMI aged below 90 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal females aged below 90 years\n* Informed written consent\n* TTC or NSTEMI / STEMI undergoing coronary angiography within 24 hours of symptom onset\n\nExclusion Criteria:\n\n* Delayed coronary angiography (\\> 24 hours after symptom onset)\n* Inability to perform rsfMRT within the first 72 hours after coronary angiography\n* Inability to communicate in German language\n* Contraindications for a MRT examination (including pacemaker, implantable cardioverter-defibrillator, mechanical heart valves, claustrophobia, severe adipositas)\n* Drug addiction, under guardianship\n* Inability to stick to the follow up examination'}, 'identificationModule': {'nctId': 'NCT02240056', 'acronym': 'TAKINSULA', 'briefTitle': 'Brain fMRT In Takotsubo Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Pilot Study: Central Nervous System and Hormonal Changes In Takotsubo Cardiomyopathy', 'orgStudyIdInfo': {'id': 'TAKINSULA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TTC', 'description': 'postmenopausal women with acute Takotsubo cardiomyopathy (TTC), diagnosis by coronary angiography within 24 hours of symptom onset'}, {'label': 'NSTEMI / STEMI', 'description': 'postmenopausal women with acute ST elevation myocardial infarction (NSTEMI / STEMI), diagnosis by coronary angiography within 24 hours of symptom onset'}, {'label': 'healthy subjects', 'description': 'healthy postmenopausal women without coronary artery disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Wolfgang Dichtl, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfgang Dichtl, MD PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Priv.Doz. DDr.', 'investigatorFullName': 'Wolfgang Dichtl, MD PhD', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}