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Clinical Trials/NCT03744533
NCT03744533
Completed
Not Applicable

Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis: a Prospective, Random, Multi-Center, Pilot Trial

General Hospital of Shenyang Military Region1 site in 1 country96 target enrollmentNovember 26, 2018
ConditionsIschemic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
General Hospital of Shenyang Military Region
Enrollment
96
Locations
1
Primary Endpoint
proportion of modified Rankin Score of 0 to 2
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Currently, the guideline recommended re-perfusion such as intravenous thrombolysis and mechanical thrombectomy as the most effective treatment for acute ischemic stroke. However, the two methods are restricted by a strict time window, which greatly limits the number of the patients receiving treatment. The abundant studies have suggested that good collateral circulation can provide compensatory blood supply to save the ischemic penumbra and reduces the infarct volume, which improves the prognosis. How to improve collateral circulation in an efficient and safe way is a clinical challenge. Our recent experiment results of the animal and preliminary clinical experiments show that head-down position may significantly increase cerebral perfusion and improve neurological function. Clinically, head-down position is simple and easy to operate, and theoretically may increases brain perfusion and improve collateral circulation. A pilot randomized clinical trial is designed to investigate the effect of head-down position combined with routine rehabilitation in patients with ischemic stroke.The study is designed to explore the efficacy and safety of head-down position in patients with acute ischemic stroke

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
August 28, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
General Hospital of Shenyang Military Region
Responsible Party
Principal Investigator
Principal Investigator

Hui-Sheng Chen

Department Chairman

General Hospital of Shenyang Military Region

Eligibility Criteria

Inclusion Criteria

  • Patient age over 18 years
  • acute ischemic stroke within 24 h of onset
  • neurological deficit: 6≤NIHSS≤16
  • Large artery atherosclerosis etiology based on TOAST typing
  • the supplied vessel is the middle cerebral artery or internal carotid artery, and the degree of stenosis was more than 50%.
  • first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
  • Signed informed consent

Exclusion Criteria

  • Disturbance of consciousness
  • Hemorrhagic stroke or mixed stroke
  • Combining with severe organ dysfunction
  • Past hemorrhagic stroke
  • A history of stroke with severe sequelae
  • Planned revascularization within 3 months
  • Ischemic stroke due to surgical intervention
  • participating in other clinical trials within 3 months
  • Pregnant or lactating women
  • any inappropriate patient assessed by the researcher

Outcomes

Primary Outcomes

proportion of modified Rankin Score of 0 to 2

Time Frame: 90 days

Secondary Outcomes

  • Proportion of modified Rankin Score of 0 to 1(90 days)
  • proportion of early neurological deterioration(48 hours)
  • The occurence of stroke or other vascular events(90 days)
  • proportion of death of any cause(90 days)

Study Sites (1)

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