Clinical trial NCT03910569: The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study
Official title: Smidt Heart Institute Takotsubo Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Takotsubo Cardiomyopathy
Keywords: Takotsubo
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with Prevalence of the Takotsubo
timeFrame: Baseline, Annual follow-up up to 30years
measure: Number of participants with Recurrence the Takotsubo
timeFrame: Baseline, Annual follow-up up to 30years
measure: Annual update surveys will collect data on patient's prospective health status following Takotsubo event
timeFrame: Baseline, Annual follow-up up to 30years
measure: Risk factors affecting which patients, having had one Takotsubo event, will more likely experience a Takotsubo reoccurrence or related subsequent adverse event
timeFrame: Baseline, Annual follow-up up to 30years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: C. Noel Bairey Merz, MD, FACC
role: STUDY_DIRECTOR
References: