NCT03105141

Optimized Remote Ischemic Conditioning (RIC) Treatment for Patients With Chronic Cerebral Ischemia

The Impact of Repeated Bilateral Limb Remote Ischemic Conditioning on Patients With Chronic Cerebral Ischemia: Establishment of Optimized Algorithm on the Basis of Feasibility, Safety and Efficacy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, single-center clinical trial is designed to figure out the most optimal algorithm of remote ischemic conditioning on patients with chronic cerebral ischemia.

Detailed description

Chronic cerebral ischemia (CCI) refers to a prevalent pathophysiological condition in which cerebral hypoperfusion is caused by a reduction in cerebral blood flow over a long period of time. CCI, as a consequence of intracranial atherosclerotic stenosis (ICAS) has been identified as one of the major culprits that are responsible for occurrence/recurrence of acute cerebrovascular accidents such as ischemic stroke and transient ischemic attack, as well as vascular cognitive dysfunction. The prevalence of ICAS related CCI among stroke patients is remarkably higher in the Chinese population than in the whites, and there are no quite effective therapies for the general patient population with ICAS up to now. Endovascular intervention appears to be a promising option for a group of patients with severe ICAS, but may not be applicable for those with certain vascular risk features that are supposed to increase the rate of complications or result in unsatisfactory clinical outcomes. In addition, high cost and adverse effects of medications pose huge burdens to patients, their families and even the whole society as well. RIC is a novel therapeutic approach whereby repetitive, transient, non-lethal ischemia intervened by reperfusion employed on a distant organ or tissue confers protection to targeted organs against subsequent major ischemic attack. Preclinical experimental studies have demonstrated the neuroprotective effects of RIC in ischemic stroke models. Meanwhile, small-scale, proof of concept clinical trials revealed that long-term RIC was able to lower the stroke recurrence and enhance the cerebral reperfusion, without inducing adverse events in patients with ICAS. Nevertheless, current protocol of RIC utilited in this scenario was mainly based on previous animal studies or cardiovascular clinical trials. Whether modifying the ischemic pressure, numbers of cycles, duration of ischemia as well as the method for application can lead to different outcomes remain to be settled. In this study, 600 patients satisfied with the inclusion criteria will be recruited and randomly allocated into four substudies to receive RIC treatment (Doctormate®) under different algorithms. The most optimal algorithm of RIC on patients with ICAS related CCI would be determined according to clinical endpoints. Other medical managements are guaranteed based on the best medical judgment from clinical practitioners.

Conditions

• Chronic Cerebral Ischemia
• Intracranial Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Remote ischemic conditioning	Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to a given pressure followed by deflation, twice daily for 12 months. Two different magnitude of limb ischemia pressure will be set: 200 mmHg and 40 mmHg above systolic pressure (60 patients for each). Optimal inflating pressure will be determined based on the results.
DEVICE	Remote ischemic conditioning	Remote ischemic conditioning is composed of a given cycle of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months. The number of cycles of limb ischemia will be set as: 4, 5 and 6 (60 patients for each). Optimal cycles for application will be determined based on the results.
DEVICE	Remote ischemic conditioning	Remote ischemic conditioning is composed of 5 cycles of a given duration of bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months. The duration of each cycle for limb ischemia will be set as: 4, 5 and 6-min (60 patients for each). Ischemia duration algorithm will be determined based on the results.
DEVICE	Remote ischemic conditioning	Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, once or twice daily for 12 months. The method for application will be set as: once daily for 12 months and twice daily for 12 months (60 patients for each).

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-04-01
• Completion: 2020-01-01
• First posted: 2017-04-07
• Last updated: 2017-12-05

Locations

2 sites across 1 country: China