Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

NCT06010641 | Recruiting DMC

• 1 other identifier: Y (2023) 148
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.

Conditions

Stroke, Acute Ischemic

Outcome Measures

Primary Outcomes (1)

• proportion of favorable functional outcome

  favorable functional outcome defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

  90±7 days

Secondary Outcomes (9)

• proportion of excellent functional outcome

  90±7 days

• ordinal distribution of modified Rankin Score (mRS)

  90±7 days

• early neurological deterioration (END)

  48±12 hours

• early neurological improvement (ENI)

  48±12 hours

• Changes in National Institute of Health stroke scale (NIHSS)

  48±12 hours

Other Outcomes (4)

• changes in cortical oxygen saturation determined by near infrared spectroscopy

  24±8 hours

• changes in cortical oxygen saturation determined by near infrared spectroscopy

  48±12 hours

• changes in serum biomarkers

  48±12 hours

Study Arms (2)

Head-down position

EXPERIMENTAL

head-down position as an adjunct to guideline-based treatment

Other: head-down position

control

OTHER

guideline-based treatment

Other: head-down position

Interventions

head-down position OTHER

-20° Trendelenburg as an adjunct to guideline-based treatment,

Head-down position; control

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Acute ischemic stroke confirmed by NCCT or MRI;
• Moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours of onset, or progressing from mild (NIHSS ≤ 5) to moderate neurologic deficit (6≤ NIHSS ≤ 16) within 24 hours, requiring ≥ 4 point increase in NIHSS score although the onset time is beyond 24 hours;
• Probable large artery atherosclerosis etiology based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria (responsible artery stenosis ≥ 50% or occlusion);
• Anterior circulation stroke (internal carotid artery, M1 or M2 of middle cerebral artery);
• First stroke onset or past stroke without obvious neurological deficit (mRS≤2);
• Signed informed consent.

You may not qualify if:

• Pre-stroke disability (mRS≥3);
• Patients with disturbance of consciousness;
• Patients who plan to undergo or have completed thrombolysis or mechanical thrombectomy;
• Hemorrhagic stroke or combined ischemic and hemorrhagic stroke;
• Serious comorbidity, such as liver or kidney insufficiency, malignant tumor, etc;
• Other stroke etiologies, such as cardiogenic embolism, arteritis, arterial dissection, moyamoya disease, etc;
• Previous history of intracerebral hemorrhage within 1 year;
• Any contraindication to head-down position (e.g. active vomiting, pneumonia, uncontrolled heart failure);
• Planned carotid or intracranial revascularization within 3 months;
• Severe uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 100 mmHg);
• Cardiac insufficiency (NYHA Class ≥II);
• Pregnant or lactating women;
• Comorbidity with other serious diseases;
• Participating in other clinical trials within 3 months;
• Patients not suitable for the study considered by researcher.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

Related Publications (1)

• Li X, Guo Z, Wang L, Wang Y, Nguyen T, Yang Y, Chen HS. Trendelenburg position for acute anterior circulation ischaemic stroke with large artery atherosclerosis aetiology (HOPES 3): rationale and design. Stroke Vasc Neurol. 2024 Nov 5;9(5):574-579. doi: 10.1136/svn-2023-002868.

  PMID: 38296589 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

CN (1)