The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease

This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Procedure: Remote ischemic preconditioning (RIPC)

• Study Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing P.R.
    • Xicheng District, Beijing P.R., China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Patients with stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA)
2. Age between 18 to 80 years old
3. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
4. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4.
5. ABCD2 score between 6 to 7
6. Stable vital signs, normal hepatic and renal functions,
7. No hemorrhagic tendencies.

Exclusion criteria:

1. Within 72 hrs of intra-artery or intravenous thrombolysis
2. Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
3. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
4. Acute myocardial infarction
5. Systolic blood pressure more than 200 mmHg after drug control
6. Peripheral blood vessel disease
7. Hematologic disease
8. Severe hepatic and renal dysfunction
9. Severe or unstable concomitant disease
10. Cannot tolerate BLIPC or without informed consent
11. Patients who did not complete the whole treatment procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC+stroke secondary prevension; Procedure/Surgery: Remote Ischemic Preconditioning (RIPC) The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day. Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal)	Procedure: Remote ischemic preconditioning (RIPC); The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
No Intervention: stroke secondary prevention; Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure and Heart Rates;		at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Plasma Biomarkers of Coagulation and Fibrinolysis	blood samples were collected one hour after every times of BLIPC procedure ended, and assayed with the immuno-turbidimetry assay on the coagulation laboratory autoanalyzer	the time points of baseline and 1, 15 and 30 days after BLIPC treatment
Number of Patients Who Got New Brain Lesions	We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)	300 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Time Point Until the First Stroke Recurrence,	These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.	At the 300-day after the initial treatment
Brain Perfusion Improvement Are Evaluated With SPECT and TCD	Brain perfusion status were evalvated by SPECT SPECT scanning was performed using a dual headed rotating gamma camera at 30 minutes after intravenous 99mTc-ECD (25mCi) bolus injection and at 40 minutes after 18F -FDG bolus injection.	300-day after treatment

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: National Natural Science Foundation of China

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (Estimate): March 24, 2011

Study Record Updates

• Last Update Posted (Estimate): April 25, 2012
• Last Update Submitted That Met QC Criteria: March 30, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: remote ischemic preconditioning; ischemic cerebral vascular disease; stroke secondary prevention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: RIPC2011