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

NCT ID: NCT03744533

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2021-08-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

head-down position treatment

Group Type: EXPERIMENTAL

head-down position treatment

Intervention Type: 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.

guideline-based treatment

Intervention Type: OTHER

guideline-based treatment

guideline-based treatment

Group Type: ACTIVE_COMPARATOR

guideline-based treatment

Intervention Type: OTHER

guideline-based treatment

Interventions

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.

Intervention Type: OTHER

guideline-based treatment

guideline-based treatment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Department Chairman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huisheng Chen, Doctor

Role: STUDY_CHAIR

Neurology Department

Locations

General Hospital of ShenYang Military Region

Shenyang, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37147320 (View on PubMed)

Other Identifiers

k （2018）38

Identifier Type: -

Identifier Source: org_study_id