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CompletedNCT01570231Updated Jul 27, 2012

Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians

A Phase 1 interventional study of bilateral limb ischemic preconditioning (Doctormate, IPC-906X) in Bilateral Limb Ischemic Preconditioning and Intracranial Arterial Stenosis, sponsored by Ji Xunming. Completed at 1 site in China. Open to participants aged 80 Years to 95 Years. Per ClinicalTrials.gov, last updated 2012-07-27.

Sponsored by Ji Xunming · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
80 Years to 95 Years
Sex
All
01

Study summary

Making a limb transiently ischemic induces ischemic tolerance in distant organs such as the heart. This study aims to evaluate the feasibility, safety and initial efficacy of using briefly repetitive bilateral limb ischemic preconditioning (BLIPC) to protect the brain in octogenarians with symptomatic intracranial arterial stenosis.

02

Conditions studied

  • Bilateral Limb Ischemic Preconditioning
  • Intracranial Arterial Stenosis

Keywords

  • remote ischemic preconditioning
  • octogenarian
  • intracranial arterial stenosis
  • stroke recurrence
03

In context

Ischemia

2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.

This study's enrollment of 58 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.

Browse Ischemia studies →

Lead sponsor

Ji Xunming is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
80 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age between 80 to 95 years old
  2. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
  3. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4
  4. ABCD2 score between 6 to 7
  5. stable vital signs, normal hepatic and renal functions
  6. no hemorrhagic tendencies

Exclusion criteria

Exclusion Criteria:

  1. within 72 hrs of intra-artery or intravenous thrombolysis
  2. intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
  3. any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
  4. acute myocardial infarction
  5. systolic blood pressure more than 200 mmHg after drug control
  6. peripheral blood vessel disease
  7. hematologic disease
  8. severe hepatic and renal dysfunction
  9. severe or unstable concomitant disease
  10. cannot tolerate BLIPC or without informed consent
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    bilateral limb ischemic preconditioning (BLIPC)

    5 minutes bilateral limb ischemic preconditioning treatment with an inflating tourniquets to 200 mmHg

    Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X)

  • No intervention
    Control group

    underwent equivalent medical treatments only

Interventions

  • Devicebilateral limb ischemic preconditioning (Doctormate, IPC-906X)

    Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.

06

What researchers measure

Primary outcomes

  1. objective signs of tissue or neurovascular injury

    objective signs of tissue or neurovascular injury felt to be due to cuff inflation, which was based on the judgment of the observers (blinded to study protocol) precluded continuation. Inspection included palpation of distal radial pulses, visual inspection (for local edema, redness, skin breakdown), and palpation for tenderness

    Time frame: 180 days after treatment

  2. levels of plasma biomarkers

    levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored

    Time frame: 180-day

07

Study locations

1 site
  • Capital Medical University
    Beijing, 100038, China
08

References and documents

Publications

  • Meng R, Ding Y, Asmaro K, Brogan D, Meng L, Sui M, Shi J, Duan Y, Sun Z, Yu Y, Jia J, Ji X. Ischemic Conditioning Is Safe and Effective for Octo- and Nonagenarians in Stroke Prevention and Treatment. Neurotherapeutics. 2015 Jul;12(3):667-77. doi: 10.1007/s13311-015-0358-6. PubMed 25956401 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01570231
Lead sponsor
Ji Xunming
Collaborators
Capital Medical University
Responsible party
Ji Xunming (Professor, Capital Medical University) — Sponsor-investigator
First posted
Apr 4, 2012
Start date
Jan 2008
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jul 27, 2012
View the source record on ClinicalTrials.gov ↗

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