Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

NCT ID: NCT01672515

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

RIPC group

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.

Group Type: EXPERIMENTAL

RIPC group

Intervention Type: DEVICE

Control group

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.

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: DEVICE

Interventions

RIPC group

Intervention Type: DEVICE

Control group

Intervention Type: DEVICE

Other Intervention Names

Brand name: Doctormate; Type: IPC-906X; Productor: Beijing Renqiao Institute of Neuroscience; Brand name: Doctormate; Type: modified version of IPC-906X; Productor: Beijing Renqiao Institute of Neuroscience

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming

Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2012-RIPC-cerebral infarction

Identifier Type: -

Identifier Source: org_study_id