Psychosocial Support for Patients With Takotsubo Syndrome
- Conditions
- Takotsubo Cardiomyopathy
- Interventions
- Behavioral: Takotsubo Support Group
- Registration Number
- NCT05977049
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
The study hypothesis is that participants enrolled in a virtual Takotsubo support group will have significantly less anxiety at one year.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Takotsubo Support Group Takotsubo Support Group Participants diagnosed with Takotsubo Syndrome will be enrolled into the study.
- Primary Outcome Measures
Name Time Method Change in anxiety level as measured by the STAI. Baseline, One year State Trait Anxiety Inventory (STAI):
Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety
- Secondary Outcome Measures
Name Time Method Changes in depression as measured by the PHQ-8. Baseline, One year 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 DepressionChanges in quality of life as measured by the KCCQ. Baseline, One year 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
Trial Locations
- Locations (1)
Weill Cornell Medicine
🇺🇸New York, New York, United States