Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

NCT01672515 | Unknown Phase 1 DMC

• 1 other identifier: 2012-RIPC-cerebral infarction
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Infarct volume evaluation before RIPC treatment.

  Acute phase of ischemic stroke, and before RIPC treatment

• Infarct volume after RIPC treatment in ischemic stroke patients

  30 days after RIPC treatment in ischemic stroke patients

Study Arms (2)

RIPC group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

RIPC group DEVICE

Also known as: Brand name: Doctormate, Type: IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience

RIPC group

Control group DEVICE

Also known as: Brand name: Doctormate, Type: modified version of IPC-906X, Productor: Beijing Renqiao Institute of Neuroscience

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 40 to 80 Years
• Ischemic cerebrovascular disease within 6 hours
• National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
• Cranial CT to rule out the the cerebral hemorrhage
• Written informed consent was

You may not qualify if:

• Cerebral hemorrhage
• Other parts of the active bleeding disease
• Atrial fibrillation
• Moyamoya disease or vasculitis
• Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
• Out coagulation disorder
• Severe lesions of severe liver and kidney disease, malignancy or other systemic
• Cannot tolerate BLIPC or without informed consent

Sponsors & Collaborators

• Capital Medical University: lead

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery, Vice-President of Xuan Wu Hospital, Capital Medical University

Study Record Dates

• First Submitted: August 19, 2012
• First Posted: August 27, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Last Updated: August 27, 2012

Record last verified: 2012-08