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

Phase 1

Completed

• Conditions: Cerebrovascular Disease
• Interventions: Procedure: Remote ischemic preconditioning (RIPC)

• Registration Number: NCT01321749
• Lead Sponsor: Capital Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Primary Completion: 2011-12
• Results First Submitted: 2012-01-11
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-30
• Last Update Submitted: 2012-03-30
• Results First Posted: 2012-04-25
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC+stroke secondary prevension	Remote ischemic preconditioning (RIPC)	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)

Primary Outcome Measures

Name	Time	Method
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	the time points of baseline and 1, 15 and 30 days after BLIPC treatment	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
Number of Patients Who Got New Brain Lesions	300 days after treatment	We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)

Secondary Outcome Measures

Name	Time	Method
The Time Point Until the First Stroke Recurrence,	At the 300-day after the initial treatment	These patients underwent MRI/DWI at the time of first recurrence; patients without symptoms recurrence underwent follow-up MRI/DWI at 300 days.
Brain Perfusion Improvement Are Evaluated With SPECT and TCD	300-day after treatment	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.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Xicheng District, Beijing P.R., China