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

This study has been completed.
Sponsor:
Collaborator:
Capital Medical University
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01570231
First received: March 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • objective signs of tissue or neurovascular injury [ Time Frame: 180 days after treatment ] [ Designated as safety issue: Yes ]
    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

  • levels of plasma biomarkers [ Time Frame: 180-day ] [ Designated as safety issue: Yes ]
    levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored


Enrollment: 58
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   80 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570231

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

No publications provided

Responsible Party: Ji Xunming, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT01570231     History of Changes
Other Study ID Numbers: 2009
Study First Received: March 25, 2012
Last Updated: July 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Capital Medical University:
remote ischemic preconditioning
octogenarian
intracranial arterial stenosis
stroke recurrence

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

ClinicalTrials.gov processed this record on June 18, 2013