Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT）

Phase 3RecruitingNCT06559241

Capital Medical University2,105 enrolled

Overview

For patients with acute ischemic stroke caused by large vessel occlusion, endovascular thrombectomy has been demonstrated to be the most effective therapy, as approximately 90% of the occluded vessels can be recanalized. However, less than 50% of patients could achieve functional independence, and over 15% died 90 days after stroke. Although the mismatch of successful recanalization with poor prognosis can be attributed to many factors, the infarct core formed during thrombectomy and reperfusion injury after thrombectomy may be among the most important and effective neuroprotective strategies urgently needed. Remote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confer protection against prolonged and severe ischemia in distant organs. In the transient focal cerebral ischemia-reperfusion model, the application of remote ischemic conditioning before reperfusion or both before and after reperfusion reduces reperfusion injuries and the final infarct size. Because patients with acute ischemic stroke who are treated with endovascular thrombectomy can achieve a high rate of recanalization after focal ischemia, this patient population is akin to the model of transient focal cerebral ischemia-reperfusion. Furthermore, a pilot study has determined the safety and feasibility of remote ischemic conditioning in patients undergoing endovascular thrombectomy. However, whether remote ischemic conditioning could provide clinical benefits to patients with acute ischemic stroke who are treated with endovascular thrombectomy urgently needs investigations. This study aims to investigate the safety and efficacy of remote ischemic conditioning in improving functional outcomes of patients with acute ischemic stroke treated with endovascular thrombectomy and explore the effect of treatment duration on the treatment outcome of remote ischemic conditioning.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

14-day remote ischemic conditioningDEVICE

RIC is a noninvasive therapy performed by an electric auto-control device with a cuff placed on the upper arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of the cuff on the upper arm. The procedure will be performed once before endovascular thrombectomy and twice daily for 14 days post-thrombectomy.

30-day remote ischemic conditioningDEVICE

Endovascular thrombectomyPROCEDURE

Endovascular thrombectomy procedures are performed according to the guidelines to recanalize the occluded large vessel safely.

Best medical managementDRUG

Best medical management is prescribed at the discretion of the treating physicians according to the guidelines.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age≥18 years； 2. Acute ischemic stroke due to large vessel occlusion in the anterior circulation that is not suitable for intravenous thrombolytic therapy, or has contraindications to intravenous thrombolytic therapy, or treated with intravenous thrombolytic therapy without recanalization; 3. Large vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA), including the occlusion of the intracranial segment of the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA), is the cause of symptoms, and mechanical thrombectomy is planned within 24 hours from the time last known well; 4. Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points; 5. Patients or family members signed a written informed consent form. Exclusion Criteria: 1. Imaging examination revealed the presence of multiple vascular supply areas of cerebral infarction (such as the simultaneous presence of infarction in both anterior and posterior circulation); 2. Absence of femoral artery pulsation, extremely difficult intravascular access, or extremely tortuous large vessels, which are expected to result in the inability to undergo timely endovascular treatment; 3. Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg; 4. Coma or lethargy patients (consciousness level score ≥2 in NIHSS); 5. Unable to obtain an accurate baseline NIHSS score; 6. Pre-stroke modified Rankin Scale (mRS) score \>1; 7. Baseline ASPECTS score ≤5; 8. Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR \> 3.0; 9. Baseline blood glucose \<2.7mmol/L or \>22.2mmol/L; 10. Baseline platelet count \< 30\*10\^9/L; 11. Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate \<30mL/min; 12. Cranial CT or MRI shows intracranial hemorrhage; 13. Cranial CT or MRI shows midline deviation and significant occupying effect; 14. Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection; 15. History of head injury in the past 3 months; 16. History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys; 17. Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding； 18. The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months; 19. Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy; 20. Participating in other ongoing clinical trials; 21. Other conditions that the investigators believe are not suitable for participation in this study.

Locations (56)

Suzhou Municipal Hospital of Anhui Province

Suzhou, Anhui, China

RECRUITING

Taihe County People's Hospital

Taihe Chengguanzhen, Anhui, China

RECRUITING

Tongling People's Hospital

Tongling, Anhui, China

RECRUITING

Beijing Luhe Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

Time frame: 90 days after stroke.

Secondary Outcomes

Two dichotomous mRS scores at 90 days (0-1 vs 2-6, 0-3 vs 4-6, 0-4 vs 5-6, 0-5 vs 6).

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

Time frame: 90 days after stroke.

The ordinal distribution of mRS scores at 90 days.

The mRS ranges from 0 to 6, with higher scores indicating worse outcomes.

Time frame: 90 days after stroke.

The proportion of patients with early neurological improvement 24 hours after endovascular procedures.

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes. Neurological improvement is defined as the NIHSS recovering to ≤2 points or decreasing by 8 points or much higher as compared with the baseline.

Time frame: 24 hours after endovascular procedures.

Changes in NIHSS score from baseline to day 14 or at discharge (whichever comes earlier).

The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.

Time frame: 14 days or at discharge (whichever comes first)

Score of EQ-5D-5L at 90 days.

EQ-5D-5L is a tool used to assess health status, including five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A higher score indicates a better health status, while a lower score indicates a poorer health status.

Time frame: 90 days after stroke.

Cerebral infarct volume.

The infarction volume will be assessed on cranial CT or MRI imaging.

Time frame: 72 hours after endovascular procedures.

The change of infarct volume.

Infarct Expansion Ratio (IER, IER=infarct volume/baseline infarct volume). The infarction volume will be assessed on cranial CT or MRI imaging, and baseline infarct volume will be assessed on the CTP or baseline MRI imaging.

Time frame: 72 hours after endovascular procedures.

Incidence of intracranial hemorrhage.

Intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.

Time frame: Within 14 days after endovascular procedures.

Incidence of Symptomatic Intracranial Hemorrhage

Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III).

Time frame: Within 14 days after endovascular procedures.

Incidence of neurological deterioration within 14 days.

Neurological deterioration is defined as an increase of ≥4 points in NIHSS compared to before deterioration within 14 days.

Time frame: Within 14 days after endovascular procedures.

Incidence of malignant infarction

Malignant infarction is defined as infarction involving more than half of the affected middle cerebral artery area, a significant mass effect requiring decompressive craniectomy, and/or directly leading to death with clinical signs of brain herniation.

Time frame: 0-90 days

All cause of death.

The incidence of death events at any time from randomization through day 90.

Time frame: 0-90 days

Incidence of Adverse Events/Serious Adverse Events

The incidence of other adverse events and serious adverse events at any time from randomization through day 90.

Time frame: 0-90 days

Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT）

Overview

Conditions

Interventions

Eligibility

Locations (56)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts