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

Primary Purpose

Bilateral Limb Ischemic Preconditioning, Intracranial Arterial Stenosis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
bilateral limb ischemic preconditioning (Doctormate, IPC-906X)
Sponsored by
Ji Xunming
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bilateral Limb Ischemic Preconditioning focused on measuring remote ischemic preconditioning, octogenarian, intracranial arterial stenosis, stroke recurrence

Eligibility Criteria

80 Years - 95 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

bilateral limb ischemic preconditioning (BLIPC)

Control group

Arm Description

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

underwent equivalent medical treatments only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 25, 2012
Last Updated
July 26, 2012
Sponsor
Ji Xunming
Collaborators
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01570231
Brief Title
Feasibility, Safety and Efficacy of Remote Ischemic Preconditioning for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Official Title
Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ji Xunming
Collaborators
Capital Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Limb Ischemic Preconditioning, Intracranial Arterial Stenosis
Keywords
remote ischemic preconditioning, octogenarian, intracranial arterial stenosis, stroke recurrence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bilateral limb ischemic preconditioning (BLIPC)
Arm Type
Experimental
Arm Description
5 minutes bilateral limb ischemic preconditioning treatment with an inflating tourniquets to 200 mmHg
Arm Title
Control group
Arm Type
No Intervention
Arm Description
underwent equivalent medical treatments only
Intervention Type
Device
Intervention Name(s)
bilateral limb ischemic preconditioning (Doctormate, IPC-906X)
Intervention Description
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.
Primary Outcome Measure Information:
Title
objective signs of tissue or neurovascular injury
Description
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
Title
levels of plasma biomarkers
Description
levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored
Time Frame
180-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 80 to 95 years old Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4 ABCD2 score between 6 to 7 stable vital signs, normal hepatic and renal functions no hemorrhagic tendencies Exclusion Criteria: within 72 hrs of intra-artery or intravenous thrombolysis intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory) any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs acute myocardial infarction systolic blood pressure more than 200 mmHg after drug control peripheral blood vessel disease hematologic disease severe hepatic and renal dysfunction severe or unstable concomitant disease cannot tolerate BLIPC or without informed consent
Facility Information:
Facility Name
Capital Medical University
City
Beijing
ZIP/Postal Code
100038
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25956401
Citation
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.
Results Reference
derived

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

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