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临床试验/NCT05977049
NCT05977049招募中不适用

Psychosocial Support for Patients With Takotsubo Syndrome

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Change in anxiety level as measured by the STAI.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - All patients with documented diagnosis of Takotsubo Syndrome greater than 18 years old.

排除标准

  • 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.

结局指标

主要结局

Change in anxiety level as measured by the STAI.

时间窗: 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

次要结局

  • Changes in depression as measured by the PHQ-8.(Baseline, One year)
  • Changes in quality of life as measured by the KCCQ.(Baseline, One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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