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NCT Number: NCT03910569

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90005, United States

Location status: Recruiting

Location contact

Jenna Maughan

CONTACT

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with Prevalence of the Takotsubo

    Time frame: Baseline, Annual follow-up up to 30years

    Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.

  2. Number of participants with Recurrence the Takotsubo

    Time frame: Baseline, Annual follow-up up to 30years

    Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.

  3. Annual update surveys will collect data on patient's prospective health status following Takotsubo event

    Time frame: Baseline, Annual follow-up up to 30years

    Prospective statusof the Takotsubo will be measured annually. Change from baseline will be assessed.

  4. Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event

    Time frame: Baseline, Annual follow-up up to 30years

    Risk factors for reoccurrence or subsequent adverse event will be collected annually.

Study contacts

Contact information is provided by the study sponsor or research team.

BS WHC, MS

CONTACT

[email protected]

310-423-9666

TS Registry

CONTACT

[email protected]

310-248-8563

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Smidt Heart Institute Takotsubo Registry

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Apr 10, 2019
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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