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Completed

NCT Number: NCT01321749

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Xuanwu Hospital, Capital Medical University

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Blood Pressure and Heart Rates;

    Time frame: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment

  2. Plasma Biomarkers of Coagulation and Fibrinolysis

    Time frame: 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

  3. Number of Patients Who Got New Brain Lesions

    Time frame: 300 days after treatment

    We compared the number of patients who got new lesions in the Diffusion-weighted magnetic resonance imaging (DWI-MRI)

Secondary outcomes

  1. The Time Point Until the First Stroke Recurrence,

    Time frame: 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.

  2. Brain Perfusion Improvement Are Evaluated With SPECT and TCD

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2008
Primary completion
2011
First posted
Mar 24, 2011
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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