Psychosocial Support for Patients With Takotsubo Syndrome

Study Overview
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Brief Summary
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The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.

Detailed Description
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Takotsubo cardiomyopathy, sometimes termed Takotsubo syndrome and broken heart syndrome, typically presents with symptoms remarkably similar to acute myocardial infarction (MI; heart attack): debilitating chest pain, shortness of breath, and a feeling of doom, among others. Takotsubo was first identified in 1990 in Japan. Most cases occur in older women. During the acute phase, the heart spontaneously undergoes apical ballooning, changing shape to resemble a takotsubo, a Japanese octopus trap. In approximately two-thirds of cases, Takotsubo is precipitated by an intense emotional or physical trigger. Typically, the heart spontaneously reverts to its previous shape within about a month. Initially, it was thought that recurrence was rare. However, more recently, recurrences have been reported in 3-15% of cases. Many patients experience a variety of debilitating cardiac and psychological symptoms long after the initial presentation. There is no known way to prevent a recurrent event and patients are typically anxious about the possibility. Since its inception as a diagnosis, one of the hallmarks of Takotsubo has been the absence of coronary artery plaque. In a surprising finding from 2019, a study of more than 1,000 Takotsubo patients undergoing coronary angiography reported that approximately 1/3 of patients had clinically significant plaque in their coronary arteries; 1/3 had evidence of sub-clinical atherosclerosis; and 1/3 had clean coronaries, with no observable plaque. Hence, much needs to be learned about this syndrome that may affect as many as 5% of women who have been diagnosed with acute MI. Takotsubo is typically an emotionally challenging and life altering event. Strategies for primary and secondary prevention of coronary artery disease will be discussed in the virtual group sessions. Currently, there is no specialized intervention for patients diagnosed with Takotsubo Syndrome at Weill Cornell Medical Center, either in hospital or after discharge.

Official Title
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Psychosocial Support for Patients With Takotsubo Syndrome

Conditions
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Takotsubo Cardiomyopathy

Intervention / Treatment
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* Behavioral: Takotsubo Support Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old. Exclusion Criteria: Patients with a diagnosis of Takotsubo Syndrome already undergoing Psychotherapy or those who choose not to participate. Vulnerable populations such as prisoners, non-English speaking subjects, pregnant women, and subjects unable to provide written informed consent will not be included in this research.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will be placed in a virtual Takotsubo Support Group once enrolled in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Takotsubo Support Group<br>Participants diagnosed with Takotsubo Syndrome will be enrolled into the study. | Behavioral: Takotsubo Support Group<br>* Participants will undergo virtual group therapy/education. Participants will meet once every other week (at minimum), for 1 - 1.5 hours (on average). The frequency and/or length of the support group sessions may be adjusted according to participants' needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety level as measured by the STAI. | State Trait Anxiety Inventory (STAI): Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety | Baseline, One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depression as measured by the PHQ-8. | Patient Health Questionnaire depression scale (PHQ-8): Score of 0-2 = No Depression; Score of 3-5 = Mild Depression; Score of 6-8 = Moderate Depression; Score of 9-12 = Severe Depression | Baseline, One year | 
| Changes in quality of life as measured by the KCCQ. | Kansas City Quality of Life Questionnaire (KCCQ): Score of 0-24 = Very poor to poor quality of life; Score of 25-49 = Poor to fair quality of life; Score of 50-74 = Fair to good quality of life; Score of 75-100 = Good to excellent quality of life | Baseline, One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Takotsubo, Cardiomyopathy, Takotsubo Syndrome