Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-21 @ 7:47 AM
Study NCT ID:
NCT03910569
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2019-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The blood samples will undergo proteomic analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2019-03-06', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Prevalence of the Takotsubo', 'timeFrame': 'Baseline, Annual follow-up up to 30years', 'description': 'Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.'}, {'measure': 'Number of participants with Recurrence the Takotsubo', 'timeFrame': 'Baseline, Annual follow-up up to 30years', 'description': 'Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.'}, {'measure': "Annual update surveys will collect data on patient's prospective health status following Takotsubo event", 'timeFrame': 'Baseline, Annual follow-up up to 30years', 'description': 'Prospective statusof the Takotsubo will be measured annually. Change from baseline will be assessed.'}, {'measure': 'Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event', 'timeFrame': 'Baseline, Annual follow-up up to 30years', 'description': 'Risk factors for reoccurrence or subsequent adverse event will be collected annually.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Takotsubo'], 'conditions': ['Takotsubo Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '39324115', 'type': 'DERIVED', 'citation': 'Marano P, Maughan J, Obrutu O, Lauzon M, Tjoe B, Herscovici R, Moy P, Rojas N, Shufelt C, Rutledge T, Wei J, Bairey Merz CN. Evaluation of Recurrent Takotsubo Syndrome. JACC Adv. 2024 Sep 17;3(10):101247. doi: 10.1016/j.jacadv.2024.101247. eCollection 2024 Oct.'}]}, 'descriptionModule': {'briefSummary': "The Cedars-Sinai SHI Takotsubo Registry and Proteomic Study is an observational registry that will collect retrospective and prospective demographic, clinical, hemodynamic, laboratory and other diagnostic parameters, therapy and outcome data from individuals who meet the inclusion/exclusion criteria of Takotsubo Registry protocol. Subjects will also be invited to provide a blood sample utilizing a Mitra kit sent to their homes. Researchers from the Barbra Streisand Women's Heart Center will analyze Registry data to identify Takotsubo phenotypes, improve diagnostic capabilities, better predict recurrence rates, and develop targeted Takotsubo treatments.", 'detailedDescription': "Registry outreach will begin with an informational and inspirational website and will utilize social media and patient-driven activism through Facebook, blogs and Twitter modalities that have demonstrated efficiencies in other patient-centered research efforts. Subjects will upload specific clinical materials into Cedar-Sinai's web-enabled cloud storage and which will be screened by trained Smidt Heart Institute physicians. The Registry utilizes on-line, e-consent and enrollment connected to a REDCap database that will allow efficient data input for analysis. All potential subjects who have been diagnosed with Takotsubo or have been informed by their physician that they meet diagnosis criteria, will need to provide information for review that includes: hospitalization records, from the time of Takotsubo event, with laboratory data (particularly -- troponin level), ECG and CTA. Registrants will be asked to respond to annual update surveys.\n\nThe goal is to accurately understand the prevalence, recurrence and prospective status of the Takotsubo, to determine which individuals are at risk of reoccurrence or subsequent adverse event and to determine potential treatment targets to develop therapeutic strategies\n\nPrimary:\n\n* To establish a large USA-based database for patients with Takotsubo with a convenient and easy to use on-line patient-advocate registry using digital media marketing, Box cloud data access and storage, accurate case adjudication, and automated follow-up.\n* Participants will also be offered the option of participating in the Takotsubo Proteomic Registry by providing remote ambulatory Mitra blood samples.\n\nSecondary:\n\n• To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The registry will be open to all subjects who have experienced a diagnosed Takotsubo syndrome episode or have been informed by their treating physicians that they have the syndrome.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have received a diagnosis of Takotsubo from their physician and consent to enroll\n* Submit full medical records needed for Takotsubo adjudication\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Unable to provide informed consent\n* Unable to provide the necessary documentation needed for screening purposes'}, 'identificationModule': {'nctId': 'NCT03910569', 'briefTitle': 'The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Smidt Heart Institute Takotsubo Registry', 'orgStudyIdInfo': {'id': '53569'}}, 'contactsLocationsModule': {'locations': [{'zip': '90005', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jenna Maughan', 'role': 'CONTACT'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'TS Registry', 'role': 'CONTACT', 'email': 'takotsuboresearch@cshs.org', 'phone': '310-248-8563'}, {'name': 'BS WHC, MS', 'role': 'CONTACT', 'email': 'bswhc.research@cshs.org', 'phone': '310-423-9666'}], 'overallOfficials': [{'name': 'C. Noel Bairey Merz, MD, FACC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Director of Women's Heart Center", 'investigatorFullName': 'Noel Bairey Merz', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}