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

Cerebral Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04470492
• Other study ID #: RICO
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: December 2022

Study information

• Verified date: July 2020
• Source: Capital Medical University
• Contact: Xunming Ji, MD.PhD
• Phone: +86-10-83198952
• Email: jixunming[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Cerebral Atherosclerosis
• Intracranial Arteriosclerosis

Intervention

Combination Product:
• Doctormate®+Medical Management
Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.

Drug:
• Medical Management
Patients will be treated with conventional medication for 3 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month composite cardio-cerebral vascular event rate		During the first 3 months from randomization.
Secondary	Recurrence of TIA or infarction rate in the area of responsible vessel domination within 3 months		During the first 3 months from randomization.
Secondary	Changes in National Institutes of Health Stroke Scale(NIHSS) within 3 months		During the first 3 months from randomization.
Secondary	Changes in modified Rankin Scale(mRS) within 3 months		During the first 3 months from randomization.
Secondary	Changes in Barthel Index(BI) within 3 months		During the first 3 months from randomization.
Secondary	12-month composite cardio-cerebral vascular event rate		During the first 12 months from randomization.