Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic … (NCT02534545) | Clinical Trial Compass
UnknownNot Applicable
Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)
China3,000 participantsStarted 2015-10
Plain-language summary
The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial artery.
After screening period, eligible patients will be randomly allocated into 2 groups. In addition, all participants receive an usual clinical therapy.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. Male or female with age from 40 to 80 years old.
✓. Patients having an ischemic stroke or a TIA prior to randomization.
✓. The entry event is attributed to symptomatic atherosclerotic stenosis (50-99%) in an intracranial qualifying artery (carotid artery, middle cerebral artery (M1), vertebral artery, or basilar artery) that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
✓. Informed consent obtained.
Exclusion criteria
✕. Thrombolytic therapy within 24 hours prior to enrollment.
✕. Progressive neurological signs within 24 hours prior to enrollment.
✕. Cerebral venous thrombosis/stenosis.
✕. Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid (CSF) pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus.
✕. Any of the following unequivocal cardiac source of embolism: rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with the participation.
What they're measuring
1
The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke.
Timeframe: During the first 12 months from randomization.