Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01672515
• Other study ID #: 2012-RIPC-cerebral infarction
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: August 19, 2012
• Last updated: August 22, 2012
• Start date: October 2012

Study information

• Verified date: August 2012
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Stroke

Intervention

Device:
• RIPC group

• Control group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Levels of plasma biomarkers assay right before RIPC treatment	levels of CRP?TINF-a?slCAM-1 and GFAP	right before RIPC treatment (within 24hrs)	No
Primary	Levels of plasma biomarkers assay 3 days after RIPC treatment.	levels of CRP?TINF-a?slCAM-1 and GFAP	3 days after RIPC treatment.	No
Primary	Levels of plasma biomarkers assay 15 days after RIPC treatment.	levels of CRP?TINF-a?slCAM-1 and GFAP	15 days after RIPC treatment.	No
Primary	Levels of plasma biomarkers assay 30 days after RIPC treatment	levels of CRP?TINF-a?slCAM-1 and GFAP	30 days after RIPC treatment	No
Primary	Levels of plasma biomarkers assay right after RIPC treatment	levels of CRP?TINF-a?slCAM-1 and GFAP	right after RIPC treatment (within 24hrs)	No
Secondary	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	No
Secondary	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	No