Remote Ischemic Conditioning Paired With Endovascular Treatment for Acute Ischemic Stroke "RICPETAIS"

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

Ischemic stroke, which is due to the occlusion of a cerebral blood vessel, comprises nearly 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 unknown. The investigators' hypothesis is that RIC is a safe, feasible and effective strategy to reduce cerebral reperfusion injury after endovascular treatment.

Conditions

Interventions

  • Remote ischemic conditioning. Device
    Other Names: RIC
    Intervention Desc: RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 5 times.
    ARM 1: Kind: Experimental
    Label: RIC paired with endovascular treatment
    Description: RIC (remote ischemic conditioning) paired with endovascular treatment.
  • Endovascular treatment. Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: RIC paired with endovascular treatment
    Description: RIC (remote ischemic conditioning) paired with endovascular treatment.
    ARM 2: Kind: Experimental
    Label: Endovascular treatment alone
    Description: Endovascular treatment only (without RIC).

Outcomes

Type Measure Time Frame Safety Issue
Primary Final cerebral infarct volume. 3-7 days after stroke onset.
Secondary The proportion of enrolled subjects that completed all the designed RIC procedures. 0-7 days.
Secondary The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS). 0-90 days.
Secondary Change in NIHSS. 0-90 days.
Secondary Symptomatic Intracerebral Hemorrhage. 0-90 days.
Secondary Safety - Assessment of adverse events and serious adverse events. 0-90 days.

Sponsors