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

This study has been completed.
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Ji Xunming, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01321749
First received: March 23, 2011
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cerebrovascular Disease
 Procedure: Remote ischemic preconditioning (RIPC)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Blood Pressure and Heart Rates; [ Time Frame: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment ] [ Designated as safety issue: Yes ]
  • Plasma Biomarkers of Coagulation and Fibrinolysis [ Time Frame: the time points of baseline and 1, 15 and 30 days after BLIPC treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 300 days after treatment ] [ Designated as safety issue: Yes ]
    We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)


Secondary Outcome Measures:
  • The Time Point Until the First Stroke Recurrence, [ Time Frame: At the 300-day after the initial treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 300-day after treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 196
Study Start Date: January 2008
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321749

Locations
China, Beijing P.R.
Xuanwu Hospital, Capital Medical University
Xicheng District, Beijing P.R., China, 100053
Sponsors and Collaborators
Capital Medical University
National Natural Science Foundation of China
  More Information

No publications provided

Responsible Party: Ji Xunming, Xuan Wu Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT01321749     History of Changes
Other Study ID Numbers: RIPC2011
Study First Received: March 23, 2011
Results First Received: January 11, 2012
Last Updated: March 30, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Capital Medical University:
ischemic cerebral vascular disease
stroke secondary prevention
remote ischemic preconditioning

Additional relevant MeSH terms:
Cerebrovascular Disorders
Vascular Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013