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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03663348
Other study ID # 09-0746
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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