Clinical trial NCT03663348: Registry of Patients With Takotsubo Syndrome
Official title: NYU Takotsubo (Broken Heart Syndrome) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Takotsubo Cardiomyopathy
Broken Heart Syndrome
Tako-tsubo Cardiomyopathy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with history of takotsubo syndrome

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosis of takotsubo syndrome
* Age\>18 years

Exclusion Criteria:

- Lack of capacity to provide informed consent

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: up to 10 years
Secondary outcomes:
measure: Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire
timeFrame: every four months up to 10 years
measure: Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)
timeFrame: every four months up to 10 years
measure: Depression assessed using the Patient Health Questionnaire (PHQ-9)
timeFrame: every four months up to 10 years
measure: Perceived stress is measured using the Perceived Stress Scale (PSS-10)
timeFrame: every four months up to 10 years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
References: