Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: RIPC group; Device: Control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: RIPC group; Other Names: Brand name: Doctormate; Type: IPC-906X; Productor: Beijing Renqiao Institute of Neuroscience
Sham Comparator: 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.	Device: Control group; Other Names: Brand name: Doctormate; Productor: Beijing Renqiao Institute of Neuroscience; Type: modified version of IPC-906X

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tissue damage 30 days after RIPC treatment	Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage	30 days after RIPC treatment
Levels of plasma biomarkers assay right before RIPC treatment	levels of CRP、TINF-α、slCAM-1 and GFAP	right before RIPC treatment (within 24hrs)
Levels of plasma biomarkers assay 3 days after RIPC treatment.	levels of CRP、TINF-α、slCAM-1 and GFAP	3 days after RIPC treatment.
Levels of plasma biomarkers assay 15 days after RIPC treatment.	levels of CRP、TINF-α、slCAM-1 and GFAP	15 days after RIPC treatment.
Levels of plasma biomarkers assay 30 days after RIPC treatment	levels of CRP、TINF-α、slCAM-1 and GFAP	30 days after RIPC treatment
Levels of plasma biomarkers assay right after RIPC treatment	levels of CRP、TINF-α、slCAM-1 and GFAP	right after RIPC treatment (within 24hrs)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infarct volume evaluation before RIPC treatment.	MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment.	Acute phase of ischemic stroke, and before RIPC treatment
Infarct volume after RIPC treatment in ischemic stroke patients	Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment	30 days after RIPC treatment in ischemic stroke patients

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): October 1, 2013

Study Registration Dates

• First Submitted: August 19, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 27, 2012

Study Record Updates

• Last Update Posted (Estimate): August 27, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Cerebral Infarction
• Other Study ID Numbers: 2012-RIPC-cerebral infarction