NCT01570231

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

March 25, 2012

Last Update Submit

July 26, 2012

Conditions

Bilateral Limb Ischemic PreconditioningIntracranial Arterial Stenosis

Keywords

remote ischemic preconditioningoctogenarianintracranial arterial stenosisstroke recurrence

Outcome Measures

Primary Outcomes (2)

  • 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

    180 days after treatment

  • levels of plasma biomarkers

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

    180-day

Study Arms (2)

bilateral limb ischemic preconditioning (BLIPC)

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

underwent equivalent medical treatments only

Interventions

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

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.

bilateral limb ischemic preconditioning (BLIPC)

Eligibility Criteria

Age80 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Medical University

Beijing, 100038, China

Location

Related Publications (1)

  • 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.

    PMID: 25956401DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2012

First Posted

April 4, 2012

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 27, 2012

Record last verified: 2012-07

Locations

CN(1)