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Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)

Remote Ischemic Conditioning for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerotic Stenosis

NCT02534545•Ji Xunming,MD,PhD

View on ClinicalTrials.gov

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.

Detailed Description

In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) once daily for 12 months; patients in the sham RLIC group will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months. In the study, the RLIC treatment will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Sham RLIC treatment will be conducted using the same procedure but with a minimal inflation pressure of 60mmHg, which does not result in upper limb ischemia. In addition, all participants will have received their usual drug therapy according to local medical practice.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female with age from 40 to 80 years old.
•2. Patients having an ischemic stroke or a TIA prior to randomization.
•* Patient having an ischemic stroke within 30 days with mRS score≤4 at baseline.
•* Patient having a TIA within 15 days with Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline.
•3. 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).
•4. Informed consent obtained.

Exclusion Criteria

•1. Thrombolytic therapy within 24 hours prior to enrollment.
•2. Progressive neurological signs within 24 hours prior to enrollment.
•3. Cerebral venous thrombosis/stenosis.
•4. 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.
•5. 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.
•6. Uncontrolled severe hypertension \[sitting systolic blood pressure (SBP) \>180 mmHg and/or sitting diastolic blood pressure (DBP) \>110 mmHg after medication\].
•7. Patients with abnormal laboratory parameters: aspartate transaminase (AST) and/or alanine transaminase (ALT) \>3×upper limit of normal range; creatinine clearance \<0.6 ml/s and/or serum creatinine \>265 μmol/l (\>3.0 mg/dl); platelets \<100×109/L.
•8. Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
•9. Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
•10. Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
+11 more criteria

Locations (50)

Wuhu NO.2 People's Hospital

Wuhu, Anhui, China

The Hospital of Shunyi District Beijing

Beijing, Beijing Municipality, China

Beijing Huairou Hospital

Beijing, Beijing Municipality, China

Baoding No.1 Hospital

Baoding, Hebei, China

Cangzhou People Hospital

Cangzhou, Hebei, China

Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine

Cangzhou, Hebei, China

Chengde Central Hospital

Chengde, Hebei, China

Handan First Hospital

Handan, Hebei, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Shijiazhuang The First Hospital

Shijiazhuang, Hebei, China

Key Dates

Start Date

October 1, 2015

Primary Completion Date

September 1, 2019

Completion Date

September 1, 2019

Last Updated

May 24, 2018

Enrollment

3,000

ESTIMATED participants

Conditions

Intracranial Atherosclerosis

Interventions

Doctormate® (200mmHg)

DEVICE

Doctormate® (60mmHg)

DEVICE

Contacts

Xunming Ji, MD. PhD

CONTACT

+86-10-83198952 jixunming@vip.163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)

Inclusion Criteria

Exclusion Criteria

A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis

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