The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03910569
Study type	Observational [Patient Registry]
Source	Cedars-Sinai Medical Center
Contact	Nicole Tovar
Phone	310-248-6960
Email	Nicole.tovar@cshs.org
Status	Recruiting
Phase
Start date	February 1, 2019
Completion date	February 2029

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms