Clinical trial NCT04470492: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Atherosclerosis
Keywords: cerebral atherosclerotic occlusion
remote ischemic conditioning
ischemic stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female with age from 40 to 80 years old.
2. 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.
3. 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.
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 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.
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. Severe hemostatic disorder or severe coagulation dysfunction.
12. Subclavian arterial stenosis≥50% or subclavian steal syndrome.
13. Extracranial stenosis ≥50%.
14. 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.
15. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 12 months after enrollment.
16. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.
17. Life expectancy\<3 years.
18. Pregnant or breast-feeding women.
19. Unwilling to be followed up or poor compliance for treatment.
20. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.
21. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Primary outcomes:
measure: 3-month composite cardio-cerebral vascular event rate
timeFrame: During the first 3 months from randomization.
Secondary outcomes:
measure: Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months
timeFrame: During the first 3 months from randomization.
measure: Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months
timeFrame: During the first 3 months from randomization.
measure: Changes in modified Rankin Scale(mRS) within 3 months
timeFrame: During the first 3 months from randomization.
measure: Changes in Barthel Index(BI) within 3 months
timeFrame: During the first 3 months from randomization.
measure: 12-month composite cardio-cerebral vascular event rate
timeFrame: During the first 12 months from randomization.
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xunming Ji, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: