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

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

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

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Other: head-down position treatment; Other: guideline-based treatment

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenyang, China
    • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: head-down position treatment	Other: head-down position treatment; 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.; Other: guideline-based treatment; guideline-based treatment
Active Comparator: guideline-based treatment	Other: guideline-based treatment; guideline-based treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of modified Rankin Score of 0 to 2	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of early neurological deterioration	Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score	48 hours
Proportion of modified Rankin Score of 0 to 1		90 days
The occurence of stroke or other vascular events		90 days
proportion of death of any cause		90 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): August 28, 2021
• Study Completion (Actual): August 28, 2021

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: head-down position; Large Artery Atherosclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Atherosclerosis
• Other Study ID Numbers: k （2018）38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No