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NCT Number: NCT05977049

Psychosocial Support for Patients With Takotsubo Syndrome

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

Location status: Recruiting

Location contact

Dolores Reynolds, BSN

CONTACT

[email protected]

212-746-4617

Heather Glum, BSN, MPA

CONTACT

[email protected]

Jim Cheung, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Takotsubo Support Group

Behavioral

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.

Primary outcomes

  1. Change in anxiety level as measured by the STAI.

    Time frame: 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 outcomes

  1. Changes in depression as measured by the PHQ-8.

    Time frame: 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 Depression

  2. Changes in quality of life as measured by the KCCQ.

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dolores Reynolds, BSN

CONTACT

[email protected]

212-746-4617

Heather Glum, BSN, MPA

CONTACT

[email protected]

212-746-4617

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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