NCT07237542

Brief Summary

This study aims to conduct a prospective, randomized, double-blind, multicenter, parallel-controlled, group-sequential trialto scientifically evaluate the safety and efficacy of remote ischemic preconditioning (RIC) in preventing early neurological deterioration (END) in patients with acute perforating artery infarction (PAI).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
910

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Nov 2027

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 11, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2027

Last Updated

February 3, 2026

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

November 16, 2025

Last Update Submit

January 30, 2026

Conditions

Ischemic StrokeRemote Ischaemic Preconditioning

Keywords

perforating artery strokeremote ischemic preconditioningearly neurological deteriorationrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • The incidence of early neurological deterioration

    an increase of ≥2 points in the National Institutes of Health Stroke Scale (NIHSS), including an increase of ≥1 point in the motor score. NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits).

    5 days after randomization

Secondary Outcomes (7)

  • The incidence of early neurological deterioration

    2 days after randomization

  • Proportion of patients with a modified Rankin Scale score of 0-1

    90 days after randomization

  • The incidence of early neurological improvement

    5 days after randomization

  • The incidence of early neurological improvement

    2 days after randomization

  • The incidence of major adverse cardiovascular events

    90 days after randomization

  • +2 more secondary outcomes

Other Outcomes (4)

  • The incidence of adverse events related to RIC

    within 90 days from randomization

  • The incidence of mortality

    within 90 days from randomization

  • The incidence of adverse events

    within 90 days from randomization

  • +1 more other outcomes

Study Arms (2)

RIC group

EXPERIMENTAL

The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg.

Device: remote ischemic preconditioning

shame RIC group

SHAM COMPARATOR

The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg.

Device: sham remote ischemic preconditioning

Interventions

remote ischemic preconditioningDEVICE

The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 200 mmHg.

RIC group
sham remote ischemic preconditioningDEVICE

The standard RIC procedure involves placing a blood pressure cuff on both upper limbs, rapidly inflating the cuff to occlude arterial blood flow and induce transient limb ischemia, followed by deflating the cuff to restore blood perfusion. RIC is administered twice daily on both upper limbs, with each session consisting of 5 cycles, for 5-7 consecutive days. The inflation pressure for RIC treatment is set at 60 mmHg.

shame RIC group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older;
  • Diagnosed with acute ischemic stroke;
  • Clinical symptoms consistent with perforating artery infarction (NIHSS score ≤5, with consciousness item 1a ≤1);
  • Time from onset to randomization within 48 hours;
  • Diffusion-weighted imaging (DWI) showing a single infarct in the perforating artery territory with a maximum diameter ≤30 mm, meeting at least one of the following:
  • (1) Diameter ≤15 mm and involving two or more axial slices; (2) Maximum diameter ≥15 mm; (3) Connected to the ventral surface of the pons but not crossing the midline; 6) Stenosis of parent artery \<70%; 7) Signed informed consent obtained from the patient or their legally authorized representative.

You may not qualify if:

  • Received intravenous thrombolysis or endovascular treatment prior to randomization;
  • Secondary stroke caused by brain tumor, traumatic brain injury, hematologic disorders, or other conditions;
  • History of intracranial hemorrhage;
  • Presence of RIC contraindications, such as severe upper limb soft tissue injury, fracture, subclavian artery stenosis, or peripheral vascular disease;
  • Uncontrolled severe hypertension (systolic blood pressure \[BP\] ≥180 mmHg or diastolic BP ≥110 mmHg);
  • Severe hepatic or renal dysfunction (Alanine Aminotransferase or Aspartate Aminotransferase \> 3 × upper limit of normal; creatine kinase \>3 × upper limit of normal; estimated Glomerular Filtration Rate \< 30 mL / min / 1.73 m²);
  • Patients with thrombocytopenic purpura, coagulation disorders, or active visceral bleeding;
  • Patients in the acute phase of fundus hemorrhage;
  • History of severe aphasia or psychiatric disorders affecting clinical assessment;
  • Life expectancy \<90 days;
  • Pregnancy;
  • Inability to comply with follow-up;
  • Participation in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinling Hospital, Medical School of Nanjing University, Nanjing

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Wusheng Zhu, PhD

CONTACT

+86 2584801861wusheng.zhu@nju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label, blinded outcome assessment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

December 11, 2025

Primary Completion (Estimated)

November 20, 2027

Study Completion (Estimated)

November 20, 2027

Last Updated

February 3, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)