Remote Ischemic Conditioning for Avoiding Recurrence of Symptomatic Intracranial Atherosclerotic Stenosis (sICAS)

Intracranial Atherosclerosis Clinical Trial

Official title:

Remote Ischemic Conditioning for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerotic Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02534545
• Other study ID #: RICA
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: September 2019

Study information

• Verified date: May 2018
• 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) compared with sham RLIC (placebo) treatment reduces the 12-month risk of recurrent IS in patients with a recent TIA or IS caused by stenosis of a major intracranial 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) once daily for 12 months; patients in the sham RLIC group will be treated with the Renqiao Remote Ischemic Conditioning Device (Doctormate®) (60mmHg) once daily for 12 months. 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. Sham RLIC treatment will be conducted using the same procedure but with a minimal inflation pressure of 60mmHg, which does not result in upper limb ischemia. In addition, all participants will have received their usual drug therapy according to local medical practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• 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 having an ischemic stroke or a TIA prior to randomization.

• Patient having an ischemic stroke within 30 days with mRS score=4 at baseline.

• Patient having a TIA within 15 days with Oxfordshire Community Stroke Project on the basis of age, blood pressure (BP), clinical features, and duration of TIA symptoms (ABCD2) score=4 at baseline.

3. The entry event is attributed to symptomatic atherosclerotic stenosis (50-99%) in an intracranial qualifying artery (carotid artery, middle cerebral artery (M1), vertebral artery, or basilar artery) that is documented by magnetic resonance angiography (MRA) or computed tomographic angiography (CTA).

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 stenosis 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
• Constriction, Pathologic
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Recurrence

Intervention

Device:
• Doctormate® (200mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
• Doctormate® (60mmHg)
Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.

Locations

Country	Name	City	State
China	Ankang City Central Hospital	Ankang	Shaanxi
China	Anshanshi Changda The Hospital	Anshan	Liaoning
China	Baoding No.1 Hospital	Baoding	Hebei
China	Beijing Aerospace General Hospital	Beijing
China	Beijing Huairou Hospital	Beijing	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing
China	The Hospital of Shunyi District Beijing	Beijing	Beijing
China	Xiyuan Hospital, China Academy of Chinses Medical Sciences	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing
China	Cangzhou People Hospital	Cangzhou	Hebei
China	Hebei Province Cangzhou Hospital of Integrated Traditional and Western Medicine	Cangzhou	Hebei
China	Peace Hospital Affiliated to Changzhi Medical College Shanxi Province	Changzhi	Shanxi
China	Changzhou NO.2 People's Hospital	Changzhou	Jiangsu
China	Chaoyang Central Hospital	Chaoyang	Liaoning
China	Chengde Central Hospital	Chengde	Hebei
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liaoning
China	Dezhou People's Hospital	Dezhou	Shandong
China	Shengli Oilfield Central Hospital	Dongying	Shandong
China	Fenyang Hospital of Shanxi Medical Unversity	Fenyang	Shanxi
China	Handan First Hospital	Handan	Hebei
China	The First Clinical Hospital affiliated to Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Inner Mongolia People's Hospital	Hohhot	Inner Mongolia
China	Jinzhou Central Hopital	Jinzhou	Liaoning
China	The Third Affiliated Hospital of Liaoning Medical College	Jinzhou	Liaoning
China	Linyi People's Hospital	Linyi	Shandong
China	Luohe Central Hospital	Luohe	Henan
China	Rizhao Hospital of Traditional Chinese Medicine	Rizhao	Shandong
China	Shangqiu First People's Hospital	Shangqiu	Henan
China	Shaoxing Central Hospital	Shaoxing	Zhejiang
China	The First People's Hospital of Shenyang	Shenyang	Liaoning
China	The General Hospital of Shenyang Military	Shenyang	Liaoning
China	The Peoele's Hospital of Liaoning Province	Shenyang	Liaoning
China	Hebei General Hospital	Shijiazhuang	Hebei
China	Shijiazhuang The First Hospital	Shijiazhuang	Hebei
China	Shijiazhuang The Third Hospital	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical Unversity	Taiyuan	Shanxi
China	Shanxi College of Traditional Chinese Medicine Hospital	Taiyuan	Shanxi
China	Tianjin 4th Centre Hospital	Tianjin	Tianjin
China	Tianjin Huanhu Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Affiliated Hospital of Weifang Medical University	Weifang	Shandong
China	Technology The Central Hospital of Wuhan	Wuhan	Hubei
China	Wuhu NO.2 People's Hospital	Wuhu	Anhui
China	The Third Houspital of Xingtai	Xingtai	Hebei
China	Xingtai People's Hospital	Xingtai	Hebei
China	Xuchang Central Hospital	Xuchang	Henan
China	Zhoushan Putuo Hospital	Zhoushan	Zhejiang
China	Zhumadian Ctentral Hospital	Zhumadian	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Ji Xunming,MD,PhD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Scores assessed by National Institutes of Health Stroke Scale(NIHSS)		During the first 12 months from randomization.
Other	Scores assessed by modified Rankin Scale(mRS)		During the first 12 months from randomization.
Other	Scores assessed by Barthel Index(BI).		During the first 12 months from randomization.
Other	Number of participants with abnormal laboratory values		3 years
Other	Number of participants with adverse events that are related to treatment		3 years
Primary	The time from randomization to the first occurrence of fatal or non-fatal ischemic stroke.		During the first 12 months from randomization.
Secondary	The time from randomization to the first occurrence of a composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and transient ischemic attack (TIA) .		During the first 12 months from randomization.
Secondary	The time from randomization to the first occurrence of each component of the composite of fatal or non-fatal stroke (ischemic and hemorrhagic), fatal or non-fatal myocardial infarction, and TIA.		During the first 12 months from randomization.
Secondary	Time to death from all causes from randomization.		During the first 12 months from randomization.