Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Capital Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Stroke

Treatments: Device: Control group; Device: RIPC group

Study type: Interventional

Funder types: Other

Identifiers

NCT01672515

2012-RIPC-cerebral infarction

Details and patient eligibility

About

Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.

Full description

This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. age between 40 to 80 Years
2. Ischemic cerebrovascular disease within 6 hours
3. National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
4. Cranial CT to rule out the the cerebral hemorrhage
5. Written informed consent was

Exclusion criteria

1. Cerebral hemorrhage
2. Other parts of the active bleeding disease
3. Atrial fibrillation
4. Moyamoya disease or vasculitis
5. Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
6. Out coagulation disorder
7. Severe lesions of severe liver and kidney disease, malignancy or other systemic
8. Cannot tolerate BLIPC or without informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

RIPC group

Experimental group

Description:

RIPC treatment was performed by the inflating tourniquets to 200mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.

Treatment:

Device: RIPC group

Control group

Sham Comparator group

Description:

RIPC sham was performed by the inflating tourniquets to 60mmHg on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days.

Treatment:

Device: Control group