Registry of Patients With Takotsubo Syndrome

Takotsubo Cardiomyopathy Clinical Trial

Official title:

NYU Takotsubo (Broken Heart Syndrome) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03663348
• Other study ID #: 09-0746
• Status: Recruiting
• Start date: September 11, 2009
• Est. completion date: August 1, 2029

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Harmony Reynolds, MD
• Email: brokenheartstudy[@]nyumc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2029
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• Physician diagnosis of takotsubo syndrome
• Age>18 years

Exclusion Criteria:

• Lack of capacity to provide informed consent

Related Conditions & MeSH terms

• Broken Heart Syndrome
• Cardiomyopathies
• Syndrome
• Tako-tsubo Cardiomyopathy
• Takotsubo Cardiomyopathy

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events	Medical record review and patient report of repeat takotsubo event, MI, heart failure, unstable angina, chest pain ER visit, cardiovascular death, stroke	up to 10 years
Secondary	Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire	Measure of quality of life	every four months up to 10 years
Secondary	Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A)	Measure of anxiety	every four months up to 10 years
Secondary	Depression assessed using the Patient Health Questionnaire (PHQ-9)	Measure of depression	every four months up to 10 years
Secondary	Perceived stress is measured using the Perceived Stress Scale (PSS-10)	Measure of perceived stress	every four months up to 10 years