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

Ischemic Stroke Clinical Trial

— HOPES2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03744533
• Other study ID #: k (2018)38
• Status: Completed
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: August 28, 2021

Study information

• Verified date: September 2021
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 28, 2021
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.
• guideline-based treatment
guideline-based treatment

Locations

Country	Name	City	State
China	General Hospital of ShenYang Military Region	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of modified Rankin Score of 0 to 2		90 days
Secondary	Proportion of modified Rankin Score of 0 to 1		90 days
Secondary	proportion of early neurological deterioration	Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score	48 hours
Secondary	The occurence of stroke or other vascular events		90 days
Secondary	proportion of death of any cause		90 days