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

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ClinicalTrials.gov Identifier: NCT03910569
Recruitment Status : Recruiting
First Posted : April 10, 2019
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center

Study Description
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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.

Condition or disease
Takotsubo Cardiomyopathy

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Smidt Heart Institute Takotsubo Registry
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 2029
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
The blood samples will undergo proteomic analysis.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910569


Contacts
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Contact: Nicole Tovar 310-248-6960 Nicole.tovar@cshs.org
Contact: BS WHC, MS 310-423-9666 bswhc.research@cshs.org

Locations
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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90005
Contact: Janet Perkins         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Study Director: C. Noel Bairey Merz, MD, FACC Cedars-Sinai Medical Center
More Information
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Additional Information:

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Responsible Party: Noel Bairey Merz, Director of Women's Heart Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03910569    
Other Study ID Numbers: 53569
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noel Bairey Merz, Cedars-Sinai Medical Center:
Takotsubo
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
 Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction