跳至主要内容
临床试验/NCT06643949
NCT06643949进行中(未招募)不适用

Takotsubo Italian Network: Italian Multicenter Observational Registry on Takostubo Syndrome

University of Molise0 个研究点目标入组 1,500 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,500
主要终点
Major Adverse Cardiovascular Events (MACE)

研究概览

简要总结

Takotsubo syndrome (TTS) has recently been described as an acquired form of cardiomyopathy whose pathophysiology is not yet well understood and mainly affects postmenopausal women. TTS or "broken heart" syndrome was first described in Japan in 1991. The Japanese term "tako-tsubo" means "polyp vessel" and describes the morphology of the left ventricular apex during systole in patients with this condition. The onset usually follows physical or emotional stress and mimics that of acute coronary syndrome (ACS) with a parade of symptoms, including chest pain, dyspnea, syncope, and nausea. Objective examination is often normal or otherwise nonspecific. ECG may document ST-T changes while echocardiogram shows areas of altered ventricular kinetics. Serum cardiac biomarkers may be increased. Currently, the gold standard method for the diagnosis of TTS is coronarography, which documents epicardial coronary arteries that are normal or free of critical lesions.

It is estimated that more than 2.5% of patients with a suspected diagnosis of ACS have TTS, and this number is probably underestimated. Although the prognosis of TTS is generally considered favorable, during the acute phase these patients can develop potentially fatal complications such as ventricular arrhythmias, cardiogenic shock, and heart rupture. Moreover, emerging scientific evidence sheds light on the need to adopt a dedicated diagnostic-therapeutic pathway for this type of patients.

The exact pathophysiology of TTS is still unknown and no large population studies or registries are currently available. Therefore, the purpose of the study is to better characterize the profile of this disease through the creation of a large registry.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with TTS in accordance with the InterTAK Diagnostic Criteria.

排除标准

  • Age less than 18 years
  • Myocarditis
  • Acute coronary syndrome
  • Myocardial infarction with non obstructive coronary arteries (MINOCA)

结局指标

主要结局

Major Adverse Cardiovascular Events (MACE)

时间窗: 1 year

Composite of acute heart failure, takotsubo recurrence and mortality.

次要结局

未报告次要终点

研究者

发起方
University of Molise
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodolfo Citro

Associate Professor

University of Molise

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