Heterogeneity and Predictors of Stress Reactivity in Takotsubo Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Mean change (in pg/mL) in plasma epinephrine levels
研究概览
简要总结
The goals of this study are as follows:
- To rigorously establish and characterize heterogeneity in the pathophysiology of Takotsubo Syndrome (TS).
- To rigorously test the contribution of TS triggering events and mental stress responsiveness to 1-year prognosis after TS event.
详细描述
Newly admitted patients with a validated diagnosis of Takotsubo Syndrome (TS; n=106) will be enrolled from 3 large medical centers in the Providence, Rhode Island area. Between 2 and 4 weeks after discharge, clinically stable patients will undergo an in-person comprehensive interview to identify the events proximal to the onset of TS symptoms, complete a battery of psychosocial questionnaires and undergo a validated laboratory stress protocol. Baseline and reactive changes in measures of autonomic nervous system activity (epinephrine and norepinephrine - primary outcome), and in the secondary outcomes of cardiac vagal control and left ventricular function (ejection fraction; regional and global longitudinal strain assessed with speckle tracking echocardiography) will be assessed. Echocardiographic evaluations will be repeated 12 months thereafter together with information on major adverse cerebrovascular events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Age >=18
- •A new diagnosis of takotsubo syndrome fulfilling Mayo Clinic criteria
- •Ability to understand and speak English
排除标准
- •Inability or unwillingness to give informed consent
- •Severe cognitive impairment
- •Uncontrolled hypertension
- •Acute psychosis
- •High suicidal risk
- •Pregnancy
- •Poor echocardiographic window
- •Conditions that would interfere with adherence to study requirements (e.g., ongoing alcohol or substance abuse)
- •If the participant is clinically unstable
研究组 & 干预措施
Stress reactivity
Stress reactivity test
干预措施: Stress reactivity test (Other)
结局指标
主要结局
Mean change (in pg/mL) in plasma epinephrine levels
时间窗: Up to 4 weeks
Blood samples for plasma epinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall levels.
Mean change (in pg/mL) in plasma norepinephrine levels
时间窗: Up to 4 weeks
Blood samples for plasma norepinephrine are collected 10-min into Baseline, 10-min into Emotion Recall, and 18 minutes into Recovery Phase. Change will be calculated by subtracting Baseline epinephrine levels from Emotion Recall norepinephrine levels.
次要结局
- Left ventricular ejection fraction (%)(12 months)
- Change in high frequency power heart rate variability (hf-HRV) in Ln msec (square)(Up to 4 weeks)
- Average Global Longitudinal Strain (GLS)(12 months)
研究者
Elena Salmoirago-Blotcher
Senior Research Scientist, Associated Professor of Medicine
The Miriam Hospital