Stroke
Conditions
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.
Interventions
DEVICERIPC group
DEVICEControl group
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of plasma biomarkers assay right after RIPC treatment | right after RIPC treatment (within 24hrs) | levels of CRP、TINF-α、slCAM-1 and GFAP |
| Levels of plasma biomarkers assay right before RIPC treatment | right before RIPC treatment (within 24hrs) | levels of CRP、TINF-α、slCAM-1 and GFAP |
| Levels of plasma biomarkers assay 30 days after RIPC treatment | 30 days after RIPC treatment | levels of CRP、TINF-α、slCAM-1 and GFAP |
| Levels of plasma biomarkers assay 3 days after RIPC treatment. | 3 days after RIPC treatment. | levels of CRP、TINF-α、slCAM-1 and GFAP |
| Levels of plasma biomarkers assay 15 days after RIPC treatment. | 15 days after RIPC treatment. | levels of CRP、TINF-α、slCAM-1 and GFAP |
| Local tissue damage 30 days after RIPC treatment | 30 days after RIPC treatment | Evaluated by the doctor blinded to the study protocol, including: local edema, redness, skin breakage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infarct volume after RIPC treatment in ischemic stroke patients | 30 days after RIPC treatment in ischemic stroke patients | Infarct volume evaluation in ischemic stroke patients after 30 RIPC treatment |
| Infarct volume evaluation before RIPC treatment. | Acute phase of ischemic stroke, and before RIPC treatment | MRI evaluation of infarct volume in ischemic stroke patients before RIPC treatment. |
Outcome results
None listed