Remote Ischemic Conditioning for Reducing Stroke Risk of Symptomatic Vertebrobasilar Lesion of Atherosclerosis

NCT02971462 | Unknown

• 1 other identifier: RIC-SVAS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate whether remote ischemic conditioning(RIC) would reduce the stroke risk of patients with symptomatic vertebrobasilar lesion of atherosclerosis,then we would observe the haemodynamics and plasma biomarkers changes.

Conditions

Vertebrobasilar Ischemia

Keywords

stroke; Vertebrobasilar atherosclerosis; remote ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• number of ischemic cerebrovascular events with vertebrobasilar responsibility

  ischemic cerebrovascular events include ischemic stroke and transient ischemic attack

  0-6 months from randomization

Secondary Outcomes (5)

• number of composite outcomes events

  0-6 months from randomization

• Number of participants with adverse events that are related to treatment

  0-6 months from randomization

• number of participants with mRS 0-1

  0-6 months from randomization

• changes of hemodynamics

  0-6 months from randomization

• changes of plasma biomarkers

  baseline，3 and 6 months

Study Arms (2)

RIC group

EXPERIMENTAL

Experimental: RIC group The upper limb ischemic conditioning is composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which is induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. This therapy started within 1 month after stroke. In addition, all participants receive a standard clinical therapy.

Device: ischemic conditioning

Control group

NO INTERVENTION

The participants receive a standard clinical therapy after diagnosed ischemic stroke.

Interventions

ischemic conditioning DEVICE

In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.

Also known as: Doctormate, IPC-906

RIC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female with age from 18 to 80 years old.
• Patients having an ischemic stroke or a TIA within 30 days and with mRS score≤4 prior to randomization.
• The entry event is attributed to symptomatic atherosclerotic lesion（stenosis is greater than or equal to 50% or occlusion）in vertebrobasilar artery that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).
• Informed consent obtained.

You may not qualify if:

• Thrombolytic therapy within 24 hours prior to enrollment.
• Progressive neurological signs within 24 hours prior to enrollment.
• Cerebral venous thrombosis/stenosis.
• vertebrobasilar lesions due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other infection; any artery 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.
• Uncontrolled severe hypertension \[sitting systolic blood pressure (SBP) \>180 mmHg and/or sitting diastolic blood pressure (DBP) \>110 mmHg after medication\].
• Patients with serious complications or 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.
• Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days prior to enrollment.
• Intracranial neoplasm, cerebral aneurysm or arteriovenous malformation.
• Known retinal hemorrhage or visceral bleeding within 30 days prior to enrollment.
• Severe hemostatic disorder or severe coagulation dysfunction.
• Subclavian arterial stenosis≥50% or subclavian steal syndrome.
• Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures within 12 months after enrollment.
• Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 6 months after enrollment.
• Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Sponsors & Collaborators

• Ji Xunming: lead

MeSH Terms

Conditions

Vertebrobasilar Insufficiency; Stroke

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Xunming Ji, MD. PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xunming Ji, MD. PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: VP,Professor

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 23, 2016

Record last verified: 2016-11