Safety and Efficacy of Remote Ischemic Conditioning in Patients with Severe Stenosis or Occlusion of Anterior Intracranial Circulation Vessels

NCT06823128 | Not Yet Recruiting DMC

• 1 other identifier: RICASO
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.

Conditions

Acute Ischemic Stroke

Keywords

Remote ischemic conditioning; anterior circulation; Acute Ischemic Stroke; Occlusion; stenosis

Outcome Measures

Primary Outcomes (1)

• Distribution of 90-day mRS scores

  The Modified Rankin Scale (mRS) measures degree of disability/dependence after a stroke, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death

  90±14 days after procedure

Secondary Outcomes (8)

• Distribution of 360-day mRS scores (to be analyzed separately in the subsequent study)

  90±14 days after procedure

• Proportion of patients with functional independence outcome (mRS 0-1) at 90-day

  90 (± 14 days) after procedure

• Proportion of patients with functional independence outcome (mRS 0-2) at 90-day

  90 (± 14 days) after procedure

• Proportion of patients with functional independence outcome (mRS 0-3) at 90-day

  90 (± 14 days) after procedure

• The proportion of early neurological deterioration

  7 (± 1 day) after procedure

Study Arms (2)

RIC group+Guideline-based therapy

EXPERIMENTAL

RIC is given twice a day with 200mmHg pressure.

Device: RIC; Other: Guideline-based therapy

Sham group+Guideline-based therapy

ACTIVE COMPARATOR

RIC is given twice a day with 60mmHg pressure.

Device: Sham; Other: Guideline-based therapy

Interventions

RIC DEVICE

Remote Ischemic Conditioning is given twice a day with 200mmHg pressure,last for 7 to 10 days.

RIC group+Guideline-based therapy

Sham DEVICE

RIC is given twice a day with 60mmHg pressure, last for 7 to 10 days.

Sham group+Guideline-based therapy

Guideline-based therapy OTHER

Guideline-based therapy

RIC group+Guideline-based therapy; Sham group+Guideline-based therapy

Eligibility Criteria

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

You may qualify if:

• Age is 18 years old or above.
• Severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (M1, M2) and anterior cerebral artery (A1, A2), which is confirmed by digital subtraction angiography (DSA), computed tomography angiography (CTA) or magnetic resonance angiography (MRA).
• Patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset.
• The NIHSS score ranges from 4 to 24.
• The mRS score before stroke is less than or equal to 1.
• informed consent.

You may not qualify if:

• Patients with vessel recanalization after mechanical thrombectomy (TICI grade ≥ 2b).
• Patients planning to receive intracranial endovascular treatment within 3 months.
• Patients with cardiogenic embolism considered as the cause, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis, etc.
• Patients diagnosed with acute posterior circulation cerebral infarction.
• Symptoms caused by non - culprit vessels.
• Ipsilateral extracranial vessel stenosis ≥ 70%.
• Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and uncontrollable by antihypertensive drugs.
• Intracranial tumors, arteriovenous malformations or aneurysms.
• Cerebral venous thrombosis or stenosis.
• Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days before enrollment.
• Severe coagulation abnormalities.
• Any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc.
• Patients with any serious diseases and a life expectancy of less than 1 year.
• Patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials.
• Patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.).

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Bites and Stings; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Hu, MD, PhD

CONTACT

+86 055162284313; andinghu@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)