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临床试验/jRCT1032230520
jRCT1032230520招募中不适用

An Uncontrolled, Open-label, Exploratory Trial Investigating Temporal Changes in Microcirculatory Dysfunction in Patients with Takotsubo Syndrome Using Pressurewire X

未提供0 个研究点目标入组 12 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
12
主要终点
microvascular resistance index by pressurewireX (Abbott)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Diagnostic Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
18age old over 至 No limit(—)
性别
All

入选标准

  • This clinical trial sets two stages of selection criteria, primary registration and secondary registration, and targets patients who meet all the criteria at each stage. Primary registration is conducted for patients suspected of having Takotsubo syndrome. Secondary registration is conducted after catheter examination.
  • Primary Registration:
  • 1, Adults aged 18 and over at the time of consent acquisition.
  • 2, Patients who have received sufficient explanation about participating in this trial, have a full understanding, and have obtained written consent by their own free will or that of a proxy.
  • 3, Patients who are hospitalized at Chiba University Hospital, or are scheduled to be hospitalized after a cardiac catheter examination.
  • 4, Patients suspected of having Takotsubo syndrome based on primary examinations (electrocardiogram, echocardiogram, blood tests, etc.).
  • Secondary Registration:
  • 1, Patients diagnosed with Takotsubo syndrome as a result of cardiac catheter examination, and who can continue to measure IMR, CFR, and CS-Lac/Ao-Lac ratio.

排除标准

  • Patients conflicting with any of the following will not be included in this clinical trial:
  • 1, Patients from whom consent cannot be obtained, either from themselves or a proxy.
  • 2, Patients deemed unsuitable as subjects by the trial responsible (sub) physician.

结局指标

主要结局

microvascular resistance index by pressurewireX (Abbott)

时间窗: acute phase - after 3 months

Changes over time (acute phase - after 3 months)

次要结局

  • coronary flow reserve(acute phase - after 3 months)
  • ratio of lactate levels(acute phase - after 3 months)

研究者

发起方
未提供

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