Phase 2
N=103
The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease
Cerebrovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01321749 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Apr 2012
Primary outcome: Primary: Blood Pressure and Heart Rates;
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Remote ischemic preconditioning (RIPC) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Capital Medical University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure and Heart Rates; |
— | — |
| PRIMARY Plasma Biomarkers of Coagulation and Fibrinolysis |
— | — |
| PRIMARY Number of Patients Who Got New Brain Lesions |
3; 8 | <0.05 sig |
| SECONDARY The Time Point Until the First Stroke Recurrence, |
— | — |
| SECONDARY Brain Perfusion Improvement Are Evaluated With SPECT and TCD |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01321749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.