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临床试验/NCT05683873
NCT05683873招募中不适用

Stroke-induced Myocardial Dysfunction: Role of GDF-15 (SMOG-15) Clinical Work Package

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2023年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
2
主要终点
Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)

研究概览

简要总结

The aim of this study is to analyze the relationship between the blood biomarker GDF-15 and heart damage after stroke.

It is being conducted in France, in the Neurology Department of the Dijon University Hospital (Burgundy). The research is interventional because a biological blood test will be performed, as well as a heart rhythm recording and several cardiac echograms during the hospitalization of the participants and during the follow-up consultation scheduled 4 to 6 months after the stroke.

A total of 130 stroke patients will participate in this study.

Participation includes 4 visits:

  • Inclusion visit (within 24 hours of the first stroke symptoms)
  • visit 1 (within 24 to 72 hours of stroke)
  • visit 2 (within 48 hours of visit 1)
  • Visit 3 (approximately 4-6 months post-stroke)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • Adult with acute symptomatic cerebral infarction documented by brain imaging on admission (cerebral angioscan or cerebral MRI)
  • Whose first symptoms appeared within 24 hours before inclusion
  • Whose consent to participate in this study was obtained from the patient or a close relative.

排除标准

  • Person with a history of symptomatic stroke, either ischemic or hemorrhagic
  • Anyone with a history of heart disease including: atrial fibrillation or flutter (known or discovered on admission), chronic heart failure, pacemaker, defibrillator, or other cardiac devices
  • Person with acute heart failure, suspected infective endocarditis, STEMI, or concurrent pulmonary embolism
  • A person who is not a member or beneficiary of a social security system
  • Person deprived of liberty
  • Person subject to a legal protection measure (curatorship, guardianship)
  • Person subject to a legal protection measure
  • Pregnant, parturient or breastfeeding woman

结局指标

主要结局

Global Longitudinal Strain (GLS) of the left ventricle measured by trans-thoracic ultrasound (TTE)

时间窗: within 24 to 72 hours post-stroke

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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