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Completed

NCT Number: NCT03744533

Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of ShenYang Military Region

Shenyang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

head-down position treatment

Other

the head position of subjects is lowered to 20 degrees in a supine position between 8:00-22:00 within 24h post-randomization as long as possible. During the procedure, when subjects feel intolerable, the head position will be elevated to lying flat (0 degree) for 5-10min, and then the above procedure is repeated. After 24h post-randomization, the head down procedures with -20 degrees in a supine position with duration of 1-1.5 hour will be performed three times daily at 9:00-11:00, 15:00-17:00 and 20:00-22:00, respectively.

guideline-based treatment

Other

guideline-based treatment

Primary outcomes

  1. proportion of modified Rankin Score of 0 to 2

    Time frame: 90 days

Secondary outcomes

  1. Proportion of modified Rankin Score of 0 to 1

    Time frame: 90 days

  2. proportion of early neurological deterioration

    Time frame: 48 hours

    Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score

  3. The occurence of stroke or other vascular events

    Time frame: 90 days

  4. proportion of death of any cause

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Acronym: HOPES2

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2018
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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