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

NCT03744533 | Completed DMC

• 1 other identifier: k （2018）38
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke

Keywords

head-down position; Large Artery Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• proportion of modified Rankin Score of 0 to 2

  90 days

Secondary Outcomes (4)

• 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 Arms (2)

head-down position treatment

EXPERIMENTAL

Other: head-down position treatment; Other: guideline-based treatment

guideline-based treatment

ACTIVE COMPARATOR

Other: guideline-based treatment

Interventions

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.

head-down position treatment

guideline-based treatment OTHER

guideline-based treatment

guideline-based treatment; head-down position treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of ShenYang Military Region

Shenyang, China

Location

Related Publications (1)

• Chen HS, Zhang NN, Cui Y, Li XQ, Zhou CS, Ma YT, Zhang H, Jiang CH, Li RH, Wan LS, Jiao Z, Xiao HB, Li Z, Yan TG, Wang DL, Nguyen TN. A randomized trial of Trendelenburg position for acute moderate ischemic stroke. Nat Commun. 2023 May 5;14(1):2592. doi: 10.1038/s41467-023-38313-y.

  PMID: 37147320 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Huisheng Chen, Doctor

  Neurology Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chairman

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 16, 2018
• Study Start: November 26, 2018
• Primary Completion: August 28, 2021
• Study Completion: August 28, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

CN (1)