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The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study

Smidt Heart Institute Takotsubo Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03910569
Enrollment
1000
Registered
2019-04-10
Start date
2019-01-03
Completion date
2029-02-01
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo

Brief summary

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.

Detailed description

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. The 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 Primary: * 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. * Participants will also be offered the option of participating in the Takotsubo Proteomic Registry by providing remote ambulatory Mitra blood samples. Secondary: • To establish a clinical trial platform for patient-centered point-of-care trials to improve diagnostics, clinical care and outcomes.

Interventions

None listed

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Have received a diagnosis of Takotsubo from their physician and consent to enroll * Submit full medical records needed for Takotsubo adjudication

Exclusion criteria

* Younger than 18 years * Unable to provide informed consent * Unable to provide the necessary documentation needed for screening purposes

Design outcomes

Primary

MeasureTime frameDescription
Annual update surveys will collect data on patient's prospective health status following Takotsubo eventBaseline, Annual follow-up up to 30yearsProspective statusof the Takotsubo will be measured annually. Change from baseline will be assessed.
Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse eventBaseline, Annual follow-up up to 30yearsRisk factors for reoccurrence or subsequent adverse event will be collected annually.
Number of participants with Prevalence of the TakotsuboBaseline, Annual follow-up up to 30yearsPrevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.
Number of participants with Recurrence the TakotsuboBaseline, Annual follow-up up to 30yearsRecurrence the Takotsubo will be measured annually. Change from baseline will be assessed.

Countries

United States

Contacts

CONTACTTS Registry
takotsuboresearch@cshs.org310-248-8563
CONTACTBS WHC, MS
bswhc.research@cshs.org310-423-9666
STUDY_DIRECTORC. Noel Bairey Merz, MD, FACC

Cedars-Sinai Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026