Effect of Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke

NCT06170944 | Recruiting DMC

• 1 other identifier: Y(2023)169
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore the influence of chronic RIC on collateral status evaluated by DSA in ischemic stroke patients with LAA etiology.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• The proportion of collateral status improvement.

  collateral status improvement is defined as an increase of ASITN/SIR score of 1 or more assessed on DSA at 12 months after randomization.

  12 months

Secondary Outcomes (6)

• The influence of RIC to neurological functions

  12 months

• Recurrence of nonfatal ischemic stroke in 12 months

  12 months

• Composite vascular events

  12 months

• Influence on heart function

  12 months

• Influence on kidney function

  12 months

Study Arms (2)

Remote ischemic preconditioning and guideline-based treatment

EXPERIMENTAL

5 cycles of cuff inflation (200mmHg for 5 minutes) and deflation (for 5 minutes), once or twice daily for 12 months.

Device: Remote ischemic preconditioning

Guideline-based treatment

NO INTERVENTION

Guideline-based treatment.

Interventions

Remote ischemic preconditioning DEVICE

The patients in experiment group will receive treatment with RIC (5 cycles of cuff inflation for 5 minutes and deflation for 5 minutes to the bilateral upper limbs to 200 mmHg) for 1 year as an adjunct to guideline-based treatment.

Remote ischemic preconditioning and guideline-based treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age over 40 years old;
• \. Diagnosed with ischemic stroke (including TIA and cerebral infarction), with onset time of more than 1 month;
• \. Culprit arteries are the large arteries of the anterior circulation with atherosclerotic stenosis (≥50%) or occlusion;
• \. ASITN/SIR collateral circulation of 0-3 based on DSA evaluation;
• \. First onset or prior onset with no significant sequelae (mRS ≤ 2);
• \. Those who are not expected to undergo angioplasty within 12 months (judged by the doctor or decided by patients and/or their representatives);
• \. The availability of informed consent.

You may not qualify if:

• \) Patients with severe infection or serious diseases such as liver, kidney, hematopoietic system, endocrine system, etc.;
• \) Patients with a history of stroke and severe sequelae (mRS≥3);
• \) arterial stenosis due to aortic dissection, moyamoya disease; Any known vasculitic disease; herpes zoster, varicella-zoster or other viral infections with vascular lesions; neurosyphilis; other intracranial infections; any intracranial artery stenosis associated with hypercytosis of cerebrospinal fluid; radiation-induced vascular lesions; myofiber dysplasia; sickle cell disease; neurofibromas; benign vascular lesions of the central nervous system; postpartum vascular disease; stenosis of the intracranial arteries due to vasospasm or thrombosm;
• \) Uncontrolled severe hypertension (systolic pressure≥180mmHg or diastolic pressure≥110 mmHg after drug treatment) ;
• \) Subclavian artery stenosis ≥50% or subclavian artery steal syndrome;
• \) Patients with intracranial hemorrhage (parenchymal hemorrhage, subarachnoid hemorrhage, subdural/epidural hemorrhage) within 90 days before enrollment;
• \) Intracranial tumor, arteriovenous malformation, or aneurysm;
• \) Patients with severe hematologic diseases or severe coagulation abnormalities;
• \) Retinal hemorrhage or visceral hemorrhage within 30 days;
• \) Those who are expected to undergo major surgery (including femoral artery, cardiac, aortic or carotid artery surgery) within 30 days before enrollment or within 12 months after enrollment;
• \) Those who have received stent implantation, angioplasty or other related medical devices for the target diseased blood vessels, or those who are expected to undergo the above treatments within 12 months after enrollment;
• \) Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.
• \) Damage and lesions in the cerebral veins;
• \) Pregnant or lactating women;
• \) Those who are participating in other clinical trials within 3 months;

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

RECRUITING

Related Publications (1)

• Zhao ZA, Lv Y, Chen HS. Effect of RICAS (Remote Ischemic Preconditioning on Collaterals of Atherosclerosis Stroke): Rationale and Design. J Am Heart Assoc. 2025 Mar 18;14(6):e038570. doi: 10.1161/JAHA.124.038570. Epub 2025 Feb 19.

  PMID: 39968799 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ziai Zhao

CONTACT

18304098115; zhaoziai@hotmail.com

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: December 5, 2023
• First Posted: December 14, 2023
• Study Start: June 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: With publication.
• Access Criteria: Researchers whose proposed use of the data has been approved.

Locations

CN (1)