NCT03045055

Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke

A Proof-of-Concept Study Assessing the Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Patients Undergoing Endovascular Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 80-90% of all strokes. Currently, reperfusion of the salvageable tissue via thrombolytic drug or endovascular treatment is the most effective strategy to reduce brain damage. However, after recanalizing the occluded vessels, subsequent reperfusion injury is inevitable. It may not only weaken the therapeutic effects of timely reperfusion but also impede patients' recovery. Moreover, thousands of neuroprotective drugs effective in experimental models have been proved to be unsuccessful in clinical trials. Therefore, effective strategies are urgently needed to prevent and treat cerebral reperfusion injury and further improve the prognosis of acute ischemic stroke. Researchers applied remote ischemic conditioning to mouse model of focal cerebral reperfusion injury and found that it could reduce cerebral infarct size. And clinical researches demonstrated that remote ischemic conditioning was an effective strategy to improve cerebral perfusion and prevent recurrent stroke in patients with ischemic stroke. However, whether remote ischemic conditioning is safe and effective in protecting patients with large-vessel ischemic stroke and undergoing endovascular treatment is still unclear. The investigators' hypothesis is that RIC is a safe and effective strategy to reduce brain injuries in stroke patients undergoing endovascular treatment.

Conditions

• Acute Stroke

Interventions

Type	Name	Description
DEVICE	Remote ischemic conditioning.	The RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
PROCEDURE	Endovascular treatment.	Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.
DEVICE	Sham remote ischemic conditioning	The sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2017-02-07
• Last updated: 2020-07-27