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Psychosocial Support for Patients With Takotsubo Syndrome

Psychosocial Support for Patients With Takotsubo Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05977049
Enrollment
24
Registered
2023-08-04
Start date
2024-04-17
Completion date
2027-12-31
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo, Cardiomyopathy, Takotsubo Syndrome

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.

Interventions

BEHAVIORALTakotsubo Support Group

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.

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All subjects will be placed in a virtual Takotsubo Support Group once enrolled in the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in anxiety level as measured by the STAI.Baseline, One yearState Trait Anxiety Inventory (STAI): Score of 20-39 = Low Anxiety; Score of 40-59 = Moderate Anxiety; Score of 60 - 80 = High Anxiety

Secondary

MeasureTime frameDescription
Changes in depression as measured by the PHQ-8.Baseline, One yearPatient 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
Changes in quality of life as measured by the KCCQ.Baseline, One yearKansas 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

Countries

United States

Contacts

CONTACTHeather Glum, BSN, MPA
hep2011@med.cornell.edu212-746-4617
CONTACTDolores Reynolds, BSN
dtr2001@med.cornell.edu212-746-4617
PRINCIPAL_INVESTIGATORJim Cheung, MD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026