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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02971462
Other study ID # RIC-SVAS
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 16, 2016
Last updated November 19, 2016
Start date November 2016
Est. completion date December 2017

Study information

Verified date November 2016
Source Capital Medical University
Contact Xunming Ji, MD. PhD
Phone +86-10-83198952
Email jixunming@vip.163.com
Is FDA regulated No
Health authority China: Beijing Municipal Science and Technology Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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.

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. 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.

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 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.

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. 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.

14. Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within previous 30 days or scheduled in the 6 months after enrollment.

15. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.

16. Pregnant or breast-feeding women.

17. Unwilling to be followed up or poor compliance for treatment.

18. Patients being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.

19. Patients unsuitable for enrollment in the clinical trial according to investigators decision making.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Device:
ischemic conditioning
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ji Xunming

Outcome

Type Measure Description Time frame Safety issue
Primary number of ischemic cerebrovascular events with vertebrobasilar responsibility ischemic cerebrovascular events include ischemic stroke and transient ischemic attack 0-6 months from randomization No
Secondary number of composite outcomes events composite outcomes events include Number of ischemic stroke ,transient ischemic attack ,cerebral hemorrhage and mortality 0-6 months from randomization No
Secondary Number of participants with adverse events that are related to treatment 0-6 months from randomization Yes
Secondary number of participants with mRS 0-1 0-6 months from randomization No
Secondary changes of hemodynamics hemodynamics evaluation by transcranial doppler 0-6 months from randomization No
Secondary changes of plasma biomarkers changes of plasma VEGF and index of thromboelastogramat at the baseline,in the first 3 and 6 months baseline,3 and 6 months No