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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01570231
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : July 27, 2012
Capital Medical University
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Bilateral Limb Ischemic Preconditioning Intracranial Arterial Stenosis Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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)
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.
No Intervention: Control group
underwent equivalent medical treatments only

Primary Outcome Measures :
  1. objective signs of tissue or neurovascular injury [ Time Frame: 180 days after treatment ]
    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

  2. levels of plasma biomarkers [ Time Frame: 180-day ]
    levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored

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Ages Eligible for Study:   80 Years to 95 Years   (Senior)
Sexes Eligible for Study:   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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01570231

Capital Medical University
Beijing, China, 100038
Sponsors and Collaborators
Ji Xunming
Capital Medical University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ji Xunming, Professor, Capital Medical University Identifier: NCT01570231     History of Changes
Other Study ID Numbers: 2009
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012

Keywords provided by Ji Xunming, Capital Medical University:
remote ischemic preconditioning
intracranial arterial stenosis
stroke recurrence

Additional relevant MeSH terms:
Constriction, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical