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

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.

Conditions

• Chronic Cerebral Ischemia
• Intracranial Atherosclerosis

Interventions

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).

Sponsors & Collaborators

• Capital Medical University

  lead OTHER

Principal Investigators

• Xuming Ji, MD, PhD · Xuanwu Hospital, Beijing

• Ran Meng, MD, PhD · Xuanwu Hospital, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2019-04-30

Completion

2020-01-31

Countries

• China

Study Locations