Registry of Patients With Takotsubo Syndrome

Recruiting

• Conditions: Tako-tsubo Cardiomyopathy; Takotsubo Cardiomyopathy; Broken Heart Syndrome

• Registration Number: NCT03663348
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2009-09-11
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2028-09-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Physician diagnosis of takotsubo syndrome
• Age>18 years

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Exclusion Criteria

• Lack of capacity to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	up to 10 years	Medical record review and patient report of repeat takotsubo event, MI, heart failure, unstable angina, chest pain ER visit, cardiovascular death, stroke

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire	every four months up to 10 years	Measure of quality of life
Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)	every four months up to 10 years	Measure of anxiety
Depression assessed using the Patient Health Questionnaire (PHQ-9)	every four months up to 10 years	Measure of depression
Perceived stress is measured using the Perceived Stress Scale (PSS-10)	every four months up to 10 years	Measure of perceived stress

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States