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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Completed

Conditions: Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03744533

k （2018）38

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

head-down position treatment

Experimental group

Treatment:

Other: head-down position treatment

Other: guideline-based treatment

guideline-based treatment

Active Comparator group

Treatment:

Other: guideline-based treatment