Characterisation of the Biochemical Profile and Physiology of the Coronary Circulation in Takotsubo Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of coronary microcirculation dysfunction
研究概览
简要总结
Consecutive consenting patients over the age of 18 years diagnosed with Takotsubo syndrome according to the position statement of the European Journal of Heart Failure (2016) will be included in the study. The primary endpoint is to evaluate the incidence of coronary microcirculation dysfunction and its correlation with the clinical presentation and the prognosis in patients with TAKO-Tsubo syndrome. Secondary endpoints will be to assess the incidence of in-hospital mortality, the prevalence of cardiogenic shock, the correlation between the levels of biomarkers analyzed, microvascular dysfunction, perceived quality of life, and angina severity during hospitalization and at subsequent follow-ups, and the influence of knowledge of the level of microvascular dysfunction on clinical management and prescribed therapies. Enrolment: 2 years, follow-up: 1 month and 1 year. Total: 3 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Diagnosis of Takotsubo syndrome
- •Signing of informed consent
排除标准
- •Age <18 years;
- •Refusal to sign written informed consent.
结局指标
主要结局
Incidence of coronary microcirculation dysfunction
时间窗: one year
coronary microvascular dysfunztion will be defined as a coronary flow reserve (CFR) \< 2.5 and/or as an index of microvascular resistance (IMR) \> 25 , as assessed with Coroventis syestem
次要结局
- Incidence of in-hospital mortality(up to thirty days)
- Correlation between the levels of biomarkers analysed and microvascular dysfunction(at discharge (assessed up to 5 days))
- Perceived quality of life(one year)
- Severity of angina(one year)