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

Ji Xunming

Status and phase: Completed; Phase 1

Conditions: Bilateral Limb Ischemic Preconditioning; Intracranial Arterial Stenosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01570231

2009

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 80 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

bilateral limb ischemic preconditioning (BLIPC)

Experimental group

Description:

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

Treatment:

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

Control group

No Intervention group

Description:

underwent equivalent medical treatments only