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

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Other: head-down position treatment; Other: guideline-based treatment

• Registration Number: NCT03744533
• Lead Sponsor: General Hospital of Shenyang Military Region

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2018-11-26
• Primary Completion: 2021-08-28
• Study Completion: 2021-08-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
head-down position treatment	guideline-based treatment	-
head-down position treatment	head-down position treatment	-
guideline-based treatment	guideline-based treatment	-

Primary Outcome Measures

Name	Time	Method
proportion of modified Rankin Score of 0 to 2	90 days

Secondary Outcome Measures

Name	Time	Method
Proportion of modified Rankin Score of 0 to 1	90 days
proportion of early neurological deterioration	48 hours	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	90 days
proportion of death of any cause	90 days

Trial Locations

Locations (1)

General Hospital of ShenYang Military Region; 🇨🇳 Shenyang, China