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

Last updated: November 11, 2024
Sponsor: Capital Medical University
Overall Status: Active - Recruiting

Phase

3

Condition

Blood Clots

Occlusions

Thrombosis

Treatment

14-day remote ischemic conditioning

30-day remote ischemic conditioning

Endovascular thrombectomy

Clinical Study ID

NCT06559241
RECAST-MT
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age≥18 years;

  2. Acute ischemic stroke due to large vessel occlusion in the anterior circulation thatis not suitable for intravenous thrombolytic therapy, or has contraindications tointravenous thrombolytic therapy, or treated with intravenous thrombolytic therapywithout recanalization;

  3. Large vessel occlusion confirmed by computed tomography angiography (CTA) ormagnetic resonance angiography (MRA), including the occlusion of the intracranialsegment of the internal carotid artery (ICA) and M1 segment of the middle cerebralartery (MCA), is the cause of symptoms, and mechanical thrombectomy is plannedwithin 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

Exclusion Criteria:

  1. Imaging examination revealed the presence of multiple vascular supply areas ofcerebral infarction (such as the simultaneous presence of infarction in bothanterior and posterior circulation);

  2. Absence of femoral artery pulsation, extremely difficult intravascular access, orextremely tortuous large vessels, which are expected to result in the inability toundergo timely endovascular treatment;

  3. Difficult-to-control hypertension: continuous monitoring upon admission showssystolic 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 oralanticoagulant 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 orperitoneal 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 suggestingintracranial tumors, arteriovenous malformations, or intracranial arterialdissection;

  15. History of head injury in the past 3 months;

  16. History of life-threatening allergy to contrast agents, nickel, titanium metal, ortheir alloys;

  17. Pregnancy, if women of childbearing age have a positive urinary or serum β-humanchorionic gonadotropin (β-hCG) test or are breastfeeding;

  18. The life expectancy of patients is less than 6 months, and they cannot be evaluatedwithin 3 months;

  19. Limb deformity, soft tissue injury, or other conditions that affect theimplementation of distant ischemia adaptation therapy;

  20. Participating in other ongoing clinical trials;

  21. Other conditions that the investigators believe are not suitable for participationin this study.

Study Design

Total Participants: 2105
Treatment Group(s): 4
Primary Treatment: 14-day remote ischemic conditioning
Phase: 3
Study Start date:
September 23, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Beijing Fangshan District First Hospital

    Beijing, Beijing 100010
    China

    Active - Recruiting

  • Beijing Luhe Hospital affiliated to Capital Medical University

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Shenzhen qianhai shekou free trade zone hospital

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • South China Hospital Affiliated to Shenzhen University

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

  • Nanning Second People's Hospital

    Nanning, Guangxi 530000
    China

    Site Not Available

  • Jiamusi university hongda hospital

    Jiamusi, Heilongjiang 154000
    China

    Site Not Available

  • Jiaozuo Coal Industry Group Co., Ltd. Central Hospital

    Jiaozuo, Henan 454000
    China

    Site Not Available

  • Luoyang Yanshi People's Hospital

    Luoyang, Henan 471000
    China

    Site Not Available

  • Henan Province People's Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Xihua county people's hospital

    Zhoukou, Henan 466600
    China

    Active - Recruiting

  • Huanggang Centralhospital

    Huanggang, Hubei 438000
    China

    Site Not Available

  • Huangshi central hospital

    Huangshi, Hubei 435000
    China

    Active - Recruiting

  • Jingmen No.1 People's Hospital

    Jingmen, Hubei 448000
    China

    Site Not Available

  • Jingmen people's hospital

    Jingmen, Hubei 448000
    China

    Site Not Available

  • First People's Hospital of Tianmen

    Tianmen, Hubei 430000
    China

    Active - Recruiting

  • Wuhan University Zhongnan Hospital

    Wuhan, Hubei 430000
    China

    Active - Recruiting

  • The First People's Hospital of Xiangyang

    Xiangyang, Hubei 441000
    China

    Active - Recruiting

  • Yichang Central People's Hospital

    Yichang, Hubei 443000
    China

    Active - Recruiting

  • the First People'S Hospital of Changde

    Changde, Hunan 415000
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Xiangya Hospital, Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia Autonomous Region 010000
    China

    Site Not Available

  • Anshan zhangda hospital

    Anshan, Liaoning Anshan
    China

    Site Not Available

  • Dalian Central Hospital

    Dalian, Liaoning 116000
    China

    Site Not Available

  • The Central Hospital of Shengli Oilfield

    Dongying, Shandong 257000
    China

    Site Not Available

  • Liaocheng Third People's Hospital

    Liaocheng, Shandong 252000
    China

    Active - Recruiting

  • The People's Hospital of Liaocheng Brain Hospital

    Liaocheng, Shandong 252000
    China

    Active - Recruiting

  • Feixian county people's hospital

    Linyi, Shandong 273400
    China

    Active - Recruiting

  • Mianyang third people's hospital

    Mianyang, Sichuan 621000
    China

    Active - Recruiting

  • Ya 'an People's Hospital

    Ya'an, Sichuan 625000
    China

    Active - Recruiting

  • Tianjin huanhu hospital

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Xuanwu Hospital, Capital Medical University

    Beijing, 100053
    China

    Active - Recruiting

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