Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 11:58 PM
Study NCT ID:
NCT04361994
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The GErman Italian Spanish Takotsubo (GEIST) Registry
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': 'ESTIMATED', 'count': 500}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2020-04-22', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'Day 0', 'description': 'All-cause mortality (in-hospital, short-term, long-term)'}, {'measure': 'All-cause mortality', 'timeFrame': '3 Month', 'description': 'All-cause mortality (in-hospital, short-term, long-term)'}, {'measure': 'All-cause mortality', 'timeFrame': '6 Month', 'description': 'All-cause mortality (in-hospital, short-term, long-term)'}], 'secondaryOutcomes': [{'measure': 'In-Hospital complications', 'timeFrame': 'Day 0', 'description': 'Cardiogenic shock, pulmonary edema, death, life-threatening arrhythmias, ventricular thrombus formation, right ventricular involvement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Takotsubo Syndrome']}, 'referencesModule': {'references': [{'pmid': '39918532', 'type': 'DERIVED', 'citation': 'Raposeiras-Roubin S, Santoro F, Arcari L, Vazirani R, Novo G, Uribarri A, Enrica M, Lopez-Pais J, Guerra F, Alfonso F, Patz T, Fernandez-Cordon C, Montisci R, Corbi-Pascual M, Marchetti MF, Almendro M, Cacciotti L, Vedia O, El-Battrawy I, Blanco-Ponce E, Brunetti ND, Akin I, Martinez-Selles M, Thiele H, Stiermaier T, Eitel I, Nunez-Gil IJ; GEIST Researchers. Beta-Blockers and Long-Term Mortality in Takotsubo Syndrome: Results of the Multicenter GEIST Registry. JACC Heart Fail. 2025 May;13(5):815-825. doi: 10.1016/j.jchf.2024.11.015. Epub 2025 Feb 5.'}, {'pmid': '39260785', 'type': 'DERIVED', 'citation': 'Santoro F, Stiermaier T, Nunez Gil IJ, El-Battrawy I, Patz T, Cacciotti L, Guerra F, Novo G, Musumeci B, Volpe M, Mariano E, Caldarola P, Montisci R, Ragnatela I, Cetera R, Vazirani R, Lluch C, Uribarri A, Corbi-Pascual M, Conty Cardona DA, Akin I, Barbato E, Thiele H, Brunetti ND, Eitel I, Arcari L. Renin angiotensin system inhibitors and outcome in patients with takotsubo syndrome: A propensity score analysis of the GEIST registry. Am Heart J. 2024 Dec;278:127-138. doi: 10.1016/j.ahj.2024.08.019. Epub 2024 Sep 10.'}, {'pmid': '38348805', 'type': 'DERIVED', 'citation': 'El-Battrawy I, Santoro F, Nunez-Gil IJ, Patz T, Arcari L, Abumayyaleh M, Guerra F, Novo G, Musumeci B, Cacciotti L, Mariano E, Caldarola P, Parisi G, Montisci R, Vitale E, Volpe M, Corbi-Pasqual M, Martinez-Selles M, Almendro-Delia M, Sionis A, Uribarri A, Thiele H, Brunetti ND, Eitel I, Akin I, Stiermaier T. Age-Related Differences in Takotsubo Syndrome: Results From the Multicenter GEIST Registry. J Am Heart Assoc. 2024 Feb 20;13(4):e030623. doi: 10.1161/JAHA.123.030623. Epub 2024 Feb 13.'}, {'pmid': '35772855', 'type': 'DERIVED', 'citation': 'Stiermaier T, Walliser A, El-Battrawy I, Patz T, Mezger M, Rawish E, Andres M, Almendro-Delia M, Martinez-Selles M, Uribarri A, Perez-Castellanos A, Guerra F, Novo G, Mariano E, Musumeci MB, Arcari L, Cacciotti L, Montisci R, Akin I, Thiele H, Brunetti ND, Nunez-Gil IJ, Santoro F, Eitel I. Happy Heart Syndrome: Frequency, Characteristics, and Outcome of Takotsubo Syndrome Triggered by Positive Life Events. JACC Heart Fail. 2022 Jul;10(7):459-466. doi: 10.1016/j.jchf.2022.02.015. Epub 2022 May 4.'}, {'pmid': '34052189', 'type': 'DERIVED', 'citation': 'El-Battrawy I, Santoro F, Stiermaier T, Moller C, Guastafierro F, Novo G, Novo S, Mariano E, Romeo F, Romeo F, Thiele H, Guerra F, Capucci A, Giannini I, Brunetti ND, Eitel I, Akin I. Incidence and Clinical Impact of Right Ventricular Involvement (Biventricular Ballooning) in Takotsubo Syndrome: Results From the GEIST Registry. Chest. 2021 Oct;160(4):1433-1441. doi: 10.1016/j.chest.2021.04.072. Epub 2021 May 27.'}]}, 'descriptionModule': {'briefSummary': 'GEIST is a multicenter, international observational registry of patients with Takotsubo syndrome. Data regarding the clinical profile (demographic characteristics, clinical presentation, laboratory measures, electrocardiography /echocardiography / coronary angiography parameters, treatment and medication), in-hospital course and complications and short-/long-term outcome are collected prospectively and retrospectively to increase the understanding of the disease.', 'detailedDescription': 'The open-ended, multicenter, international GEIST registry collects data from patients with Takotsubo syndrome during the index hospitalization and follow-up. Furthermore, long-term outcome data are acquired with structured telephone interviews, in case patients do not undergo regular outpatient visits in the participating study centers. The GEIST registry retrospectively includes data, which have already been collected, and prospectively continues to enroll patients with newly diagnosed Takotsubo syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosed according to the current diagnostic recommendations at the time of clinical presentation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Takotsubo syndrome\n\nExclusion Criteria:\n\n* Non'}, 'identificationModule': {'nctId': 'NCT04361994', 'acronym': 'GEIST', 'briefTitle': 'The GErman Italian Spanish Takotsubo (GEIST) Registry', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'The GErman Italian Spanish Takotsubo (GEIST) Registry', 'orgStudyIdInfo': {'id': '00'}}, 'contactsLocationsModule': {'locations': [{'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ingo Eitel, Prof. Dr. med.', 'role': 'CONTACT'}, {'name': 'Thomas Stiermaier, Dr.med', 'role': 'CONTACT'}], 'facility': 'Universität zu Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Foggia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Franceso Santoro, Dr.', 'role': 'CONTACT'}, {'name': 'Daniele Brunetti, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'University of Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}], 'centralContacts': [{'name': 'Ingo Eitel, Prof. Dr.', 'role': 'CONTACT', 'email': 'ingo.eitel@uksh.de', 'phone': '004945150044501'}, {'name': 'Thomas Stiermaier, Dr.', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. med. Ingo Eitel', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Foggia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Prof. Dr. med. Ingo Eitel', 'investigatorAffiliation': 'University of Luebeck'}}}}