Clinical trial NCT01672515: Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
Official title: Phase 2 Study of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Local tissue damage 30 days after RIPC treatment
timeFrame: 30 days after RIPC treatment
measure: Levels of plasma biomarkers assay right before RIPC treatment
timeFrame: right before RIPC treatment (within 24hrs)
measure: Levels of plasma biomarkers assay 3 days after RIPC treatment.
timeFrame: 3 days after RIPC treatment.
measure: Levels of plasma biomarkers assay 15 days after RIPC treatment.
timeFrame: 15 days after RIPC treatment.
measure: Levels of plasma biomarkers assay 30 days after RIPC treatment
timeFrame: 30 days after RIPC treatment
measure: Levels of plasma biomarkers assay right after RIPC treatment
timeFrame: right after RIPC treatment (within 24hrs)
Secondary outcomes:
measure: Infarct volume evaluation before RIPC treatment.
timeFrame: Acute phase of ischemic stroke, and before RIPC treatment
measure: Infarct volume after RIPC treatment in ischemic stroke patients
timeFrame: 30 days after RIPC treatment in ischemic stroke patients
Other outcomes:
Locations:
Study officials:
References: