Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning

NCT04470492 | Unknown DMC

• 1 other identifier: RICO
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of the study will be to determine whether remote limb ischemic conditioning (RLIC) together with conventional medication therapy compared with only medication therapy reduces the 3-month risk of composite cardio-cerebral vascular event in patients with a recent TIA or IS caused by occlusion of a cerebral artery. After screening period, eligible patients will be randomly allocated into 2 groups.In addition, all participants receive an usual clinical therapy.

Conditions

Cerebral Atherosclerosis

Keywords

cerebral atherosclerotic occlusion; remote ischemic conditioning; ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 3-month composite cardio-cerebral vascular event rate

  During the first 3 months from randomization.

Secondary Outcomes (5)

• Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months

  During the first 3 months from randomization.

• Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months

  During the first 3 months from randomization.

• Changes in modified Rankin Scale(mRS) within 3 months

  During the first 3 months from randomization.

• Changes in Barthel Index(BI) within 3 months

  During the first 3 months from randomization.

• 12-month composite cardio-cerebral vascular event rate

  During the first 12 months from randomization.

Study Arms (2)

Experiment

EXPERIMENTAL

Combination Product: Doctormate®+Medical Management

Control

OTHER

Drug: Medical Management

Interventions

Doctormate®+Medical Management COMBINATION_PRODUCT

Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.

Experiment

Medical Management DRUG

Patients will be treated with conventional medication for 3 months.

Control

Eligibility Criteria

• Age: 40 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 40 to 80 years old.
• Patients with cerebral arterial occlusion which have been confirmed by CTA, MRA, or other evidence (including intracranial and extracranial arterial occlusion), and there is no indication of intervention and surgery, and at the same time the patients combined more than two risk factors for atherosclerosis.
• The entry event is acute ischemic cerebrovascular disease (TIA or cerebral infarction), of which the condition was relatively stable within 30 days of onset, and mRS≤4.
• 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.
• Intracranial arterial occlusion 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.
• Uncontrolled severe hypertension \[sitting systolic blood pressure (SBP) \>180 mmHg and/or sitting diastolic blood pressure (DBP) \>110 mmHg after medication\].
• 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.
• 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.
• Extracranial stenosis ≥50%.
• 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 12 months after enrollment.

Sponsors & Collaborators

• Ji Xunming,MD,PhD: lead

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Ischemic Stroke

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: VP, Professor

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 14, 2020
• Study Start: September 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 14, 2020

Record last verified: 2020-07