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Completed

NCT Number: NCT01570231

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

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.

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Key information

Conditions

Bilateral Limb Ischemic Preconditioning Intracranial Arterial Stenosis

Age range

80 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Capital Medical University

Beijing, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ji Xunming

Other

Collaborators

  • Capital Medical University

Registry information

Official study title

Feasibility, Safety and Efficacy of RIPC for Symptomatic Intracranial Arterial Stenosis in Octogenarians

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 4, 2012
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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