Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning
Primary Purpose
Cerebral Atherosclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Doctormate®+Medical Management
Medical Management
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Atherosclerosis focused on measuring cerebral atherosclerotic occlusion, remote ischemic conditioning, ischemic stroke
Eligibility Criteria
Inclusion Criteria:
- 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.
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 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.
- Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
- Life expectancy<3 years.
- Pregnant or breast-feeding women.
- Unwilling to be followed up or poor compliance for treatment.
- Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
- Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experiment
Control
Arm Description
Outcomes
Primary Outcome Measures
3-month composite cardio-cerebral vascular event rate
Secondary Outcome Measures
Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
Changes in modified Rankin Scale(mRS) within 3 months
Changes in Barthel Index(BI) within 3 months
12-month composite cardio-cerebral vascular event rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04470492
Brief Title
Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning
Official Title
Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ji Xunming,MD,PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
In this study, Patients in the RLIC group will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication; patients in the control group will be treated only with conventional medication. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Atherosclerosis
Keywords
cerebral atherosclerotic occlusion, remote ischemic conditioning, ischemic stroke
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experiment
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Combination Product
Intervention Name(s)
Doctormate®+Medical Management
Intervention Description
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.
Intervention Type
Drug
Intervention Name(s)
Medical Management
Intervention Description
Patients will be treated with conventional medication for 3 months.
Primary Outcome Measure Information:
Title
3-month composite cardio-cerebral vascular event rate
Time Frame
During the first 3 months from randomization.
Secondary Outcome Measure Information:
Title
Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
Time Frame
During the first 3 months from randomization.
Title
Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
Time Frame
During the first 3 months from randomization.
Title
Changes in modified Rankin Scale(mRS) within 3 months
Time Frame
During the first 3 months from randomization.
Title
Changes in Barthel Index(BI) within 3 months
Time Frame
During the first 3 months from randomization.
Title
12-month composite cardio-cerebral vascular event rate
Time Frame
During the first 12 months from randomization.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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 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.
Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
Life expectancy<3 years.
Pregnant or breast-feeding women.
Unwilling to be followed up or poor compliance for treatment.
Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD.PhD
Phone
+86-10-83198952
Email
jixunming@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, MD.PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Study on Prevention and Treatment of Atherosclerotic Cerebral Occlusive Disease With Remote Ischemic Conditioning
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