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

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Nicole Tovar; Phone Number: 310-248-6960; Email: nicole.tovar@cshs.org
• Study Contact Backup: Name: BS WHC, MS; Phone Number: 310-423-9666; Email: bswhc.research@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90005
      • Recruiting
      • Cedars Sinai Medical Center
      • Contact: Jenna Maughan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Study Director: C. Noel Bairey Merz, MD, FACC, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Takotsubo
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 53569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No