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Registry of Patients With Takotsubo Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663348
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Takotsubo Cardiomyopathy Broken Heart Syndrome Tako-tsubo Cardiomyopathy

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: NYU Takotsubo (Broken Heart Syndrome) Registry
Actual Study Start Date : September 11, 2009
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : August 1, 2029

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 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 :
  1. Quality of life assessed using the Patient Reported Outcome Measurement Information System (PROMIS-10) questionnaire [ Time Frame: every four months up to 10 years ]
    Measure of quality of life

  2. Anxiety is assessed using the Hospital Anxiety and Depression Scale (HADS-A) [ Time Frame: every four months up to 10 years ]
    Measure of anxiety

  3. Depression assessed using the Patient Health Questionnaire (PHQ-9) [ Time Frame: every four months up to 10 years ]
    Measure of depression

  4. Perceived stress is measured using the Perceived Stress Scale (PSS-10) [ Time Frame: every four months up to 10 years ]
    Measure of perceived stress



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with history of takotsubo syndrome
Criteria

Inclusion Criteria:

  • Physician diagnosis of takotsubo syndrome
  • Age>18 years

Exclusion Criteria:

- Lack of capacity to provide informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663348


Contacts
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Contact: Harmony Reynolds, MD brokenheartstudy@nyumc.org
Contact: Anais Hausvater, MD brokenheartstudy@nyumc.org

Locations
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United States, New York
NYU School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Anais Hausvater, MD    646-501-6797    brokenheartstudy@nyumc.org   
Principal Investigator: Harmony Reynolds, MD         
Sponsors and Collaborators
NYU Langone Health
Additional Information:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03663348    
Other Study ID Numbers: 09-0746
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction