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NCT06559241Toboroz3. fázis

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

Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy (RECAST-MT): A Multicenter, Randomized, Controlled, Open-label, Blinded Endpoint Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 10.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Fázis (regiszter)
3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
2105 (tervezett)
Első benyújtás
2024. aug. 4.
Kezdés
2024. szept. 23.
Elsődleges befejezés
2026. nov.
Fő szponzor
Capital Medical University
NCT-szám
NCT06559241

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 3. fázis
  • Tervezett résztvevők: 2105
  • 2024. szept. 23. és az elsődleges befejezés (2026. nov.) között
  • 56 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;

Más betegség

  • Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;
  • Pre-stroke modified Rankin Scale (mRS) score >1;
  • Cranial CT or MRI shows intracranial hemorrhage;
  • History of head injury in the past 3 months;
  • History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;
  • Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;
  • Other conditions that the investigators believe are not suitable for participation in this study.

Laborértékek

  • 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;
  • Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding;

Egyéb

  • 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;
  • Coma or lethargy patients (consciousness level score ≥2 in NIHSS);
  • Unable to obtain an accurate baseline NIHSS score;
  • Baseline ASPECTS score ≤5;
  • Cranial CT or MRI shows midline deviation and significant occupying effect;
  • The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;
  • Participating in other ongoing clinical trials;

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (56)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Anshan Changda HospitalAnshanKínaToboroz
Xuanwu Hospital, Capital Medical UniversityBeijingKínaToboroz
Beijing Fangshan District First HospitalBeijingKínaToboroz
Beijing Daxing District People's HospitalBeijingKínaToboroz
Beijing Luhe Hospital affiliated to Capital Medical UniversityBeijingKínaToboroz
Beijing Red Cross Emergency Medical CenterBeijingKínaToboroz
Beijing Chao-Yang HospitalBeijingKínaToboroz
Aerospace Central HospitalBeijingKínaToboroz
Beijing Fengtai You'anmen HospitalBeijingKínaToboroz
Cangzhou Central HospitalCangzhouKínaToboroz
The First People's Hospital of ChangdeChangdeKínaToboroz
The Third Xiangya Hospital of Central South UniversityChangshaKínaToboroz
The First People's Hospital of ChenzhouChenzhouKínaToborzás még nem indult
Chongqing University Fuling HospitalChongqingKínaToborzás még nem indult
Dalian Central HospitalDalianKínaToborzás még nem indult
The First Affiliated Hospital of Dalian Medical UniversityDalianKínaToboroz
Shengli Oilfield Central HospitalDongyingKínaToboroz
Fujian Provincial HospitalFuzhouKínaToborzás még nem indult
Xunxian People's HospitalHebiKínaToboroz
Inner Mongolia Autonomous Region People's HospitalHohhotKínaToborzás még nem indult
Huanggang Central HospitalHuanggangKínaToboroz
Huangshi Central HospitalHuangshiKínaToboroz
The Hongda Hospital of Jiamusi UniversityJiamusiKínaToboroz
Jiaozuo Coal Industry (Group) Co. Ltd. Central HospitalJiaozuoKínaToboroz
Jinan Third People's HospitalJinanKínaToboroz
Jingmen People's HospitalJingmenKínaToboroz
Jingmen Central hospitalJingmenKínaToboroz
Liaocheng People's HospitalLiaochengKínaToboroz
Liaocheng Third People's HospitalLiaochengKínaToboroz
The People's Hospital of GaotangLiaochengKínaToboroz
Feixian People's HospitalLinyiKínaFelfüggesztve
Luoyang Yanshi People's HospitalLuoyangKínaToboroz
Mianyang third people's hospitalMianyangKínaToboroz
The Second Nanning People's HospitalNanningKínaToboroz
Nanyang Central HospitalNanyangKínaToboroz
South China Hospital Affiliated to Shenzhen UniversityShenzhenKínaToboroz
Shenzhen Second People's HospitalShenzhenKínaToborzás még nem indult
Hebei General HospitalShijiazhuangKínaToborzás még nem indult
Army Medical University Noncommissioned Officer School Affiliated HospitalShijiazhuangKínaToboroz
The First Affiliated Hospital of Soochow UniversitySuzhouKínaToboroz
The Fourth Affiliated Hospital of Soochow UniversitySuzhouKínaToboroz
Suzhou Municipal Hospital of Anhui ProvinceSuzhouKínaToboroz
Taihe County People's HospitalTaihe ChengguanzhenKínaToboroz
First People's Hospital of TianmenTianmenKínaFelfüggesztve
Tongling People's HospitalTonglingKínaToboroz
The Second Affiliated Hospital of Wenzhou Medical UniversityWenzhouKínaToboroz
The Third People's Hospital of Hubei ProvinceWuhanKínaToborzás még nem indult
Zhongnan Hospital of Wuhan UniversityWuhanKínaToboroz
The Central Hospital of XiangtanXiangtanKínaToborzás még nem indult
Ya 'an People's HospitalYa'anKínaToboroz
YEDA hospitalYantaiKínaToboroz
Yichang Central People's HospitalYichangKínaToboroz
Yueqing People's HospitalYueqingKínaToboroz
Zhangzhou Municipal Hospital of Fujian ProvinceZhangzhouKínaToboroz
Henan Province People's HospitalZhengzhouKínaToborzás még nem indult
Xihua County People's HospitalZhoukouKínaToboroz

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