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

Takotsubo Cardiomyopathy Clinical Trial

Official title:

Smidt Heart Institute Takotsubo Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03910569
• Other study ID #: 53569
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: February 2029

Study information

• Verified date: September 2023
• Source: Cedars-Sinai Medical Center
• Contact: Nicole Tovar
• Phone: 310-248-6960
• Email: Nicole.tovar[@]cshs.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 2029
• Est. primary completion date: February 2029
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Prevalence of the Takotsubo	Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.	Baseline, Annual follow-up up to 30years
Primary	Number of participants with Recurrence the Takotsubo	Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.	Baseline, Annual follow-up up to 30years
Primary	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.	Baseline, Annual follow-up up to 30years
Primary	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.	Baseline, Annual follow-up up to 30years