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临床试验/NCT06597331
NCT06597331招募中不适用

Prospective Observational Study of Myocardial Stunning in Patients Hospitalized for Exacerbation of Chronic Obstructive Pulmonary Disease

Sahlgrenska University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Reversible left ventricular dysfunction (myocardial stunning) according to echocardiography

研究概览

简要总结

The goal of this prospective observational study is to investigate to what extent acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) triggers Takotsubo-stunning, and how this affects the outcome for these patients.

The main questions it aims to answer are:

  1. What is cumulative incidence of Takotsubo-stunning in patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S (Gothenburg, Sweden)?
  2. Among patients hospitalized for AE-COPD at Sahlgrenska University Hospital/S, what is the risk of in-hospital clinical manifestations of acute heart failure in patients with Takotsubo-stunning compared to those without?

详细描述

PURPOSE

The purpose of Cardiac Assessment and Takotsubo-stunning among COPD-exacerbations in-Hospital (CATCH) is to investigate to what extent AE-COPD triggers Takotsubo-stunning in patients admitted to in-hospital care, and how this affects the outcome for these patients.

BACKGROUND

Acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) may cause acute heart failure due to stress-induced myocardial stunning, which is probably underdiagnosed or undiagnosed in clinical routine. Elements of myocardial stunning is associated with several conditions, however, the Takotsubo syndrome (TS) is probably a pure form of myocardial stunning. Therefore, the term "Takotsubo-stunning" is sometimes used to describe the myocardial stunning that occur in TS.

TS is an acute heart failure syndrome associated with emotional or physical stress predominately affecting females (>90% females) in the postmenopausal ages. TS is characterized by rapid onset of regional wall motion abnormality (typically widespread apical akinesia) and reversible left ventricular dysfunction. One of the most widely reported physical triggers of TS is AE-COPD and COPD is overrepresented among patients with TS. Concurrent respiratory disease such as AE-COPD complicate the diagnosis of TS, since the cardiac condition may be masked by pulmonary symptoms, and the respiratory symptoms may be further exacerbated by Takotsubo-stunning. Also, a cornerstone in the treatment for AE-COPD is high doses of beta-2-adrenergic agonists through inhalation. This may be unfavourable (and possibly detrimental) for a patient with Takotsubo-stunning, since adrenergic overstimulation in general, and overstimulation of cardiac beta-2-adrenergic receptor in particular, seems to be involved in the pathophysiology of TS.

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

  • Adult patients (≥ 18 years old) admitted to hospital ward for AE-COPD
  • Inclusion within 72 hours of admission,
  • Written informed consent

排除标准

  • Prior acute myocardial infarction or known pre-existing persistent regional wall motion abnormality or left ventricular dysfunction (left ventricular ejection fraction [LVEF] <50%)
  • Expected inability to comply with the protocol (e.g. dementia)

结局指标

主要结局

Reversible left ventricular dysfunction (myocardial stunning) according to echocardiography

时间窗: 30 days

Echocardiographic signs of myocardial stunning/Takotsubo-stunning at inclusion (day 0) with recovery of left ventricular function at day 1 and/or day 30

Clinical signs of acute heart failure at inclusion (day 0) or day 1 according to the Killip Classification

时间窗: 2 days

Acute heart failure will be defined as modified Killip Class \>1, and will be compared between patients with vs without myocardial stunning/Takotsubo-stunning

次要结局

  • In-hospital Major Adverse Cardiac Events (MACE)(At discharge from hospital (on average 5 days))
  • Admission to intensive care unit (ICU) during index hospitalization(At discharge from hospital (on average 5 days))
  • In-hospital death and death within one year(At time of in-hospital death or at discharge from hospital (on average 5 days) and after 1 year)

研究者

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

Rickard Zeijlon

MD, PhD, specialist of internal medicine

Sahlgrenska University Hospital

研究点 (2)

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