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临床试验/NCT05614401
NCT05614401已完成不适用

Long-term Efficacy of Remote Ischemic Postconditioning After Rt-PA Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: The Randomized RESPONTH Trial

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
the proportion of excellent functional outcome, %

研究概览

简要总结

The goal of this observational study is to learn about the long-term efficacy of our previous study in acute ischemic stroke(AIS) patients who underwent either remote ischemic postconditioning(RIPC) or sham treatment after intravenous thrombolysis. The main questions it aims to answer are:

  • Dose the RIPC treatment combined with IV thrombolysis can improve the long-term functional outcome in AIS patients?
  • Dose the RIPC treatment combined with IV thrombolysis can improve the incidence rates of all-cause and cardiovascular mortality, recurrent stroke/TIA, new-onset clinical AF on this long-term follow-up? A single rater (A.E.P.) trained by an experienced stroke physician (S.T.E.) contacted patients, relatives, and family physicians to gather all available medical information on the following issues: 1) survival status, 2) date of death in those who died (based on information of the treating physicians), 3) mRS score at the time of the interview, 4) recurrent stroke/TIA, 5) new onset atrial fibrillation, 6) other cardiovascular events, including myocardial infarction, pulmonary embolism, deep venous thrombosis, peripheral arteriopathy.

Researchers will compare RIPC group and control group to see if the RIPC treatment have a long-term effect in AIS patients.

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

  • All patients who completed the previous interventional rater-blinded controlled study were invited for the follow-up session.

排除标准

  • 未提供

结局指标

主要结局

the proportion of excellent functional outcome, %

时间窗: through study completion, an average of 5 year

An excellent functional outcome define as mRS= 0 and 1.

次要结局

  • recurrent stroke/TIA(From date of randomization until the date of first documented recurrent stroke/TIA or date of death from any cause, whichever came first, assessed up to 100 months)
  • the proportion of favorable outcome (mRS scores 0-2), %(through study completion, an average of 5 year)
  • incidence rates of all-cause and cardiovascular mortality, %(From date of randomization until the date of death from any cause, assessed up to 100 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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