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

NCT01321749 | Completed Phase 1 Results DMC

• 1 other identifier: RIPC2011
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Disease

Keywords

ischemic cerebral vascular disease; stroke secondary prevention; remote ischemic preconditioning

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The Time Point Until the First Stroke Recurrence,

  At the 300-day after the initial treatment

• Brain Perfusion Improvement Are Evaluated With SPECT and TCD

  300-day after treatment

Study Arms (2)

RIPC+stroke secondary prevension

EXPERIMENTAL

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)

stroke secondary prevention

NO INTERVENTION

Procedure:stroke secondary prevention(Such as Antiplatelet therapy, Cholesterol-lowering therapymaintain blood pressure and blood sugar normal)

Interventions

Remote ischemic preconditioning (RIPC) PROCEDURE

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.

RIPC+stroke secondary prevension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age between 18 to 80 years old
• Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
• National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4.
• ABCD2 score between 6 to 7
• Stable vital signs, normal hepatic and renal functions,
• No hemorrhagic tendencies.

You may not qualify if:

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

Sponsors & Collaborators

• Capital Medical University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Xicheng District, Beijing P.R., 100053, China

Location

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Xunming Ji, M.D.,Ph.D.
• Organization: XuanWu Hospital, Capital Medical University

jixm70@hotmail.com , Jixm@ccmu.edu.cn

8683198127

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xuan Wu Hospital

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Last Updated: April 25, 2012
• Results First Posted: April 25, 2012

Record last verified: 2012-03

Locations

CN (1)