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Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis (HOPES2)

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
head-down position treatment
guideline-based treatment
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring head-down position, Large Artery Atherosclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Disturbance of consciousness
  2. Hemorrhagic stroke or mixed stroke
  3. Combining with severe organ dysfunction
  4. Past hemorrhagic stroke
  5. A history of stroke with severe sequelae
  6. Planned revascularization within 3 months
  7. Ischemic stroke due to surgical intervention
  8. participating in other clinical trials within 3 months
  9. Pregnant or lactating women
  10. any inappropriate patient assessed by the researcher

Sites / Locations

  • General Hospital of ShenYang Military Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

head-down position treatment

guideline-based treatment

Arm Description

Outcomes

Primary Outcome Measures

proportion of modified Rankin Score of 0 to 2

Secondary Outcome Measures

Proportion of modified Rankin Score of 0 to 1
proportion of early neurological deterioration
Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score
The occurence of stroke or other vascular events
proportion of death of any cause

Full Information

First Posted
November 14, 2018
Last Updated
September 26, 2021
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT03744533
Brief Title
Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis
Acronym
HOPES2
Official Title
Head-down Position for Acute Ischemic Stroke With Large Artery Atherosclerosis: a Prospective, Random, Multi-Center, Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
August 28, 2021 (Actual)
Study Completion Date
August 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
head-down position, Large Artery Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
head-down position treatment
Arm Type
Experimental
Arm Title
guideline-based treatment
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
head-down position treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
guideline-based treatment
Intervention Description
guideline-based treatment
Primary Outcome Measure Information:
Title
proportion of modified Rankin Score of 0 to 2
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of modified Rankin Score of 0 to 1
Time Frame
90 days
Title
proportion of early neurological deterioration
Description
Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score
Time Frame
48 hours
Title
The occurence of stroke or other vascular events
Time Frame
90 days
Title
proportion of death of any cause
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huisheng Chen, Doctor
Organizational Affiliation
Neurology Department
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of ShenYang Military Region
City
Shenyang
Country
China

12. IPD Sharing Statement

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

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