Status:
RECRUITING
Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT）
Lead Sponsor:
Capital Medical University
Conditions:
Acute Ischemic Stroke
Anterior Circulation Brain Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Age≥18 years；
- 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;
- 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;
- Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;
- Patients or family members signed a written informed consent form.
Exclusion
- 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);
- 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;
- Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;
- Coma or lethargy patients (consciousness level score ≥2 in NIHSS);
- Unable to obtain an accurate baseline NIHSS score;
- Pre-stroke modified Rankin Scale (mRS) score \>1;
- Baseline ASPECTS score ≤5;
- Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR \> 3.0;
- Baseline blood glucose \<2.7mmol/L or \>22.2mmol/L;
- Baseline platelet count \< 30\*10\^9/L;
- Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate \<30mL/min;
- Cranial CT or MRI shows intracranial hemorrhage;
- Cranial CT or MRI shows midline deviation and significant occupying effect;
- Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;
- History of head injury in the past 3 months;
- History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
- Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding；
- The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
- Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
- Participating in other ongoing clinical trials;
- Other conditions that the investigators believe are not suitable for participation in this study.
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
2105 Patients enrolled
Trial Details
Trial ID
NCT06559241
Start Date
September 23 2024
End Date
February 1 2027
Last Update
December 10 2025
Active Locations (56)
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1
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, China, 234000
2
Taihe County People's Hospital
Taihe Chengguanzhen, Anhui, China, 236600
3
Tongling People's Hospital
Tongling, Anhui, China
4
Beijing Luhe Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100000