NCT03910569

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2019Feb 2029

Study Start

First participant enrolled

February 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

March 6, 2019

Last Update Submit

August 15, 2025

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo

Outcome Measures

Primary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Have received a diagnosis of Takotsubo from their physician and consent to enroll
  • Submit full medical records needed for Takotsubo adjudication

You may not qualify if:

  • Younger than 18 years
  • Unable to provide informed consent
  • Unable to provide the necessary documentation needed for screening purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90005, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39324115DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The blood samples will undergo proteomic analysis.

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular Dysfunction

Study Officials

  • C. Noel Bairey Merz, MD, FACC

    Cedars-Sinai Medical Center

    STUDY DIRECTOR

Central Study Contacts

TS Registry

CONTACT

310-248-8563takotsuboresearch@cshs.org

BS WHC, MS

CONTACT

310-423-9666bswhc.research@cshs.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Women's Heart Center

Study Record Dates

First Submitted

March 6, 2019

First Posted

April 10, 2019

Study Start

February 1, 2019

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)