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Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

Primary Purpose

Stroke, Acute Ischemic

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
head-down position
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 Stroke, Acute Ischemic

Eligibility Criteria

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

Inclusion Criteria: Age ≥ 18 years old Acute ischemic stroke confirmed by NCCT or MRI; Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours; Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion); Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery); First stroke onset or past stroke without obvious neurological deficit (mRS≤2); Signed informed consent. Exclusion Criteria: Pre-stroke disability (mRS≥3); Patients with disturbance of consciousness; Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy; Hemorrhagic stroke or combined ischemic and hemorrhagic stroke; Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc; Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc; Previous history of intracerebral hemorrhage within 1 year; Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure); Planned carotid or intracranial revascularization within 3 months; Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg); Cardiac insufficiency (NYHA Class ≥II); Pregnant or lactating women; Comorbidity with other serious diseases; Participating in other clinical trials within 3 months; Patients not suitable for the study considered by researcher.

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Head-down position

control

Arm Description

head-down position as an adjunct to guideline-based treatment

guideline-based treatment

Outcomes

Primary Outcome Measures

proportion of favorable functional outcome
favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Secondary Outcome Measures

proportion of excellent functional outcome
excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
ordinal distribution of modified Rankin Score (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
early neurological deterioration (END)
END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage
early neurological improvement (ENI)
ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
changes in infarct volume
new stroke or other vascular event(s)
all-cause mortality

Full Information

First Posted
August 20, 2023
Last Updated
August 23, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT06010641
Brief Title
Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)
Official Title
Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3): a Prospective, Randomized, Open-label, Blinded-endpoint, Multi-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 21, 2023 (Anticipated)
Primary Completion Date
October 21, 2024 (Anticipated)
Study Completion Date
October 21, 2024 (Anticipated)

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
The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Head-down position
Arm Type
Experimental
Arm Description
head-down position as an adjunct to guideline-based treatment
Arm Title
control
Arm Type
Other
Arm Description
guideline-based treatment
Intervention Type
Other
Intervention Name(s)
head-down position
Intervention Description
-20° Trendelenburg as an adjunct to guideline-based treatment,
Primary Outcome Measure Information:
Title
proportion of favorable functional outcome
Description
favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
proportion of excellent functional outcome
Description
excellent functional outcome is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
90±7 days
Title
ordinal distribution of modified Rankin Score (mRS)
Description
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
90±7 days
Title
early neurological deterioration (END)
Description
END is defined as more than 4-point increase in NIHSS within 48±12 hours, but was not a result of intracerebral hemorrhage
Time Frame
48±12 hours
Title
early neurological improvement (ENI)
Description
ENI is defined as more than 4-point decrease in NIHSS within 48±12 hours
Time Frame
48±12 hours
Title
Changes in National Institute of Health stroke scale (NIHSS)
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time Frame
48±12 hours
Title
Changes in National Institute of Health stroke scale (NIHSS)
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time Frame
10±2 days
Title
changes in infarct volume
Time Frame
48±12 hours
Title
new stroke or other vascular event(s)
Time Frame
90±7 days
Title
all-cause mortality
Time Frame
90±7 days
Other Pre-specified Outcome Measures:
Title
changes in cortical oxygen saturation determined by near infrared spectroscopy
Time Frame
24±8 hours
Title
changes in cortical oxygen saturation determined by near infrared spectroscopy
Time Frame
48±12 hours
Title
changes in serum biomarkers
Time Frame
48±12 hours
Title
changes in serum biomarkers
Time Frame
10±2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Acute ischemic stroke confirmed by NCCT or MRI; Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours; Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion); Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery); First stroke onset or past stroke without obvious neurological deficit (mRS≤2); Signed informed consent. Exclusion Criteria: Pre-stroke disability (mRS≥3); Patients with disturbance of consciousness; Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy; Hemorrhagic stroke or combined ischemic and hemorrhagic stroke; Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc; Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc; Previous history of intracerebral hemorrhage within 1 year; Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure); Planned carotid or intracranial revascularization within 3 months; Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg); Cardiac insufficiency (NYHA Class ≥II); Pregnant or lactating women; Comorbidity with other serious diseases; Participating in other clinical trials within 3 months; Patients not suitable for the study considered by researcher.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

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