Registry of Patients With Takotsubo Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Takotsubo Cardiomyopathy, Broken Heart Syndrome, Tako-tsubo Cardiomyopathy. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NYU Takotsubo (Broken Heart Syndrome) Registry
Overview
Takotsubo syndrome is a condition which mimics acute myocardial infarction, and is diagnosed in 1.5% to 2.2% of patients referred to hospital with suspected acute coronary syndrome. It is also known as broken heart syndrome, takotsubo cardiomyopathy, stress cardiomyopathy and apical ballooning cardiomyopathy, among other names. The pathogenesis of this disorder is not well understood. Possible mechanisms include catecholamine excess, coronary artery spasm, microvascular dysfunction, among others. This is a multicenter, nation-wide, observational study of patients who were previously diagnosed with takotsubo syndrome. The investigators aim to use this registry to help plan and carry out further studies and to improve understanding of the pathophysiologic mechanisms of this syndrome. In addition participants will be followed for events, and to monitor quality of life and stress.
Detailed description
Patients are eligible to participate if they are aged 18 years or older and carry a physician confirmed diagnosis of takotsubo syndrome. Patients with a history of takotsubo syndrome will be identified via physician referral, Epic search and patient self-referral. Patients may register directly through our registry website at www.nyulmc.org/brokenheartstudy or via direct contact with the study team via e-mail or telephone. Following completion of a research authorization form and collection of medical records, study team will confirm the diagnosis of takotsubo syndrome. Data will be collected including contact information, medical history, data on the takotsubo event(s) including physician records and all relevant imaging. Participants will also be asked quality of life questionnaires and will be followed every 4 months for events.
Primary outcome measures
- Major Adverse Cardiac Events [Time frame: up to 10 years]
Secondary outcome measures (4)
- Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire [Time frame: every four months up to 10 years]
- Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A) [Time frame: every four months up to 10 years]
- Depression assessed using the Patient Health Questionnaire (PHQ-9) [Time frame: every four months up to 10 years]
- Perceived stress is measured using the Perceived Stress Scale (PSS-10) [Time frame: every four months up to 10 years]
Eligibility criteria
Inclusion criteria
- Physician diagnosis of takotsubo syndrome
- Age>18 years
Exclusion criteria
\- Lack of capacity to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU School of Medicine — New York
Identifiers
NCT: NCT03663348 · 09-0746