The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study
ConditionTakotsubo Cardiomyopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have received a diagnosis of Takotsubo from their physician and consent to enroll
Submit full medical records needed for Takotsubo adjudication
Disqualifiers
Younger than 18 years
Unable to provide informed consent
Unable to provide the necessary documentation needed for screening purposes
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of participants with Prevalence of the Takotsubo
Prevalence of the Takotsubo will be measured annually. Change from baseline will be assessed.
Time frame
Baseline, Annual follow-up up to 30years2
Number of participants with Recurrence the Takotsubo
Recurrence the Takotsubo will be measured annually. Change from baseline will be assessed.
Time frame
Baseline, Annual follow-up up to 30years3
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.
Time frame
Baseline, Annual follow-up up to 30years4
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.
Time frame
Baseline, Annual follow-up up to 30yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov