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RecruitingNCT03910569Updated Aug 19, 2026

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

An observational study in Takotsubo Cardiomyopathy, sponsored by Cedars-Sinai Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Cedars-Sinai Medical Center · Observational

From the registry’s dates

  • Started Jan 2019; still recruiting 7 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Takotsubo Cardiomyopathy

Keywords

  • Takotsubo
03

In context

Takotsubo Cardiomyopathy

63 studies on the registry are indexed under Takotsubo Cardiomyopathy; 26 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 250 across 39 observational studies indexed under Takotsubo Cardiomyopathy.

Browse Takotsubo Cardiomyopathy studies →

Lead sponsor

Cedars-Sinai Medical Center is the lead sponsor of 456 studies on the registry; 107 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Younger than 18 years
  • Unable to provide
  • Unable to provide the necessary documentation needed for screening purposes
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
30 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Number of participants with Prevalence of the Takotsubo

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

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

  2. Number of participants with Recurrence the Takotsubo

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

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

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

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

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

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

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

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 39324115 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03910569
Responsible party
Noel Bairey Merz (Director of Women's Heart Center, Cedars-Sinai Medical Center) — Principal investigator
First posted
Apr 10, 2019
Start date
Jan 3, 2019
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Aug 19, 2026

Study contacts

TS Registry
Contact
takotsuboresearch@cshs.org
310-248-8563
BS WHC, MS
Contact
bswhc.research@cshs.org
310-423-9666
C. Noel Bairey Merz, MD, FACC
study director · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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