Takotsubo CardiomyopathyNCT03910569
The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study
An observational study of Takotsubo Cardiomyopathy, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Takotsubo Cardiomyopathy
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to Feb 2029
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Have received a diagnosis of Takotsubo from their physician and consent to enroll
- Submit full medical records needed for Takotsubo adjudication
Who cannot join
- Younger than 18 years
- Unable to provide informed consent
- Unable to provide the necessary documentation needed for screening purposes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90005
Jenna Maughan
About this study
Official title: Smidt Heart Institute Takotsubo Registry
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.
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- Takotsubo
- Medical subject headings
- Takotsubo Cardiomyopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Prevalence of the Takotsubo
Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.
Measured: Baseline, Annual follow-up up to 30years
Number of participants with Recurrence the Takotsubo
Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.
Measured: Baseline, Annual follow-up up to 30years
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.
Measured: Baseline, Annual follow-up up to 30years
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.
Measured: Baseline, Annual follow-up up to 30years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start3 Jan 2019
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C. Noel Bairey Merz, MD, FACC, Study director, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910569
- Sponsor's protocol ID
- 53569
- Status last verified
- Aug 2026
- First submitted
- 6 Mar 2019
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smidt Heart Institute Takotsubo Registry
- ClinicalTrials.gov ID
- NCT03910569
- Acronym / sponsor ID
- 53569
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- Takotsubo
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Have received a diagnosis of Takotsubo from their physician and consent to enroll
- Submit full medical records needed for Takotsubo adjudication
Key exclusion criteria (3 listed)
- Younger than 18 years
- Unable to provide informed consent
- Unable to provide the necessary documentation needed for screening purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 39324115Marano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
C. Noel Bairey Merz, MD, FACC study director
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Takotsubo Cardiomyopathy, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TS Registry (310-248-8563, takotsuboresearch@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Prevalence of the Takotsubo (time frame: Baseline, Annual follow-up up to 30years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03910569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.