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

Phase 1

Completed

• Conditions: Bilateral Limb Ischemic Preconditioning; Intracranial Arterial Stenosis
• Interventions: Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X)

• Registration Number: NCT01570231
• Lead Sponsor: Ji Xunming

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2012-03-25
• Study First Submitted QC: 2012-04-03
• Study First Posted: 2012-04-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral limb ischemic preconditioning (BLIPC)	bilateral limb ischemic preconditioning (Doctormate, IPC-906X)	5 minutes bilateral limb ischemic preconditioning treatment with an inflating tourniquets to 200 mmHg

Primary Outcome Measures

Name	Time	Method
objective signs of tissue or neurovascular injury	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
levels of plasma biomarkers	180-day	levels of plasma myoglobin at baseline and at the 1st, 15th and 30th day during BLIPC treatment were monitored

Trial Locations

Locations (1)

Capital Medical University; 🇨🇳 Beijing, China