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.
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
- Betegségek
- Stroke (szélütés)
- 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
Helyszínek (56)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Anshan Changda Hospital | Anshan | Kína | Toboroz |
| Xuanwu Hospital, Capital Medical University | Beijing | Kína | Toboroz |
| Beijing Fangshan District First Hospital | Beijing | Kína | Toboroz |
| Beijing Daxing District People's Hospital | Beijing | Kína | Toboroz |
| Beijing Luhe Hospital affiliated to Capital Medical University | Beijing | Kína | Toboroz |
| Beijing Red Cross Emergency Medical Center | Beijing | Kína | Toboroz |
| Beijing Chao-Yang Hospital | Beijing | Kína | Toboroz |
| Aerospace Central Hospital | Beijing | Kína | Toboroz |
| Beijing Fengtai You'anmen Hospital | Beijing | Kína | Toboroz |
| Cangzhou Central Hospital | Cangzhou | Kína | Toboroz |
| The First People's Hospital of Changde | Changde | Kína | Toboroz |
| The Third Xiangya Hospital of Central South University | Changsha | Kína | Toboroz |
| The First People's Hospital of Chenzhou | Chenzhou | Kína | Toborzás még nem indult |
| Chongqing University Fuling Hospital | Chongqing | Kína | Toborzás még nem indult |
| Dalian Central Hospital | Dalian | Kína | Toborzás még nem indult |
| The First Affiliated Hospital of Dalian Medical University | Dalian | Kína | Toboroz |
| Shengli Oilfield Central Hospital | Dongying | Kína | Toboroz |
| Fujian Provincial Hospital | Fuzhou | Kína | Toborzás még nem indult |
| Xunxian People's Hospital | Hebi | Kína | Toboroz |
| Inner Mongolia Autonomous Region People's Hospital | Hohhot | Kína | Toborzás még nem indult |
| Huanggang Central Hospital | Huanggang | Kína | Toboroz |
| Huangshi Central Hospital | Huangshi | Kína | Toboroz |
| The Hongda Hospital of Jiamusi University | Jiamusi | Kína | Toboroz |
| Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital | Jiaozuo | Kína | Toboroz |
| Jinan Third People's Hospital | Jinan | Kína | Toboroz |
| Jingmen People's Hospital | Jingmen | Kína | Toboroz |
| Jingmen Central hospital | Jingmen | Kína | Toboroz |
| Liaocheng People's Hospital | Liaocheng | Kína | Toboroz |
| Liaocheng Third People's Hospital | Liaocheng | Kína | Toboroz |
| The People's Hospital of Gaotang | Liaocheng | Kína | Toboroz |
| Feixian People's Hospital | Linyi | Kína | Felfüggesztve |
| Luoyang Yanshi People's Hospital | Luoyang | Kína | Toboroz |
| Mianyang third people's hospital | Mianyang | Kína | Toboroz |
| The Second Nanning People's Hospital | Nanning | Kína | Toboroz |
| Nanyang Central Hospital | Nanyang | Kína | Toboroz |
| South China Hospital Affiliated to Shenzhen University | Shenzhen | Kína | Toboroz |
| Shenzhen Second People's Hospital | Shenzhen | Kína | Toborzás még nem indult |
| Hebei General Hospital | Shijiazhuang | Kína | Toborzás még nem indult |
| Army Medical University Noncommissioned Officer School Affiliated Hospital | Shijiazhuang | Kína | Toboroz |
| The First Affiliated Hospital of Soochow University | Suzhou | Kína | Toboroz |
| The Fourth Affiliated Hospital of Soochow University | Suzhou | Kína | Toboroz |
| Suzhou Municipal Hospital of Anhui Province | Suzhou | Kína | Toboroz |
| Taihe County People's Hospital | Taihe Chengguanzhen | Kína | Toboroz |
| First People's Hospital of Tianmen | Tianmen | Kína | Felfüggesztve |
| Tongling People's Hospital | Tongling | Kína | Toboroz |
| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Kína | Toboroz |
| The Third People's Hospital of Hubei Province | Wuhan | Kína | Toborzás még nem indult |
| Zhongnan Hospital of Wuhan University | Wuhan | Kína | Toboroz |
| The Central Hospital of Xiangtan | Xiangtan | Kína | Toborzás még nem indult |
| Ya 'an People's Hospital | Ya'an | Kína | Toboroz |
| YEDA hospital | Yantai | Kína | Toboroz |
| Yichang Central People's Hospital | Yichang | Kína | Toboroz |
| Yueqing People's Hospital | Yueqing | Kína | Toboroz |
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Kína | Toboroz |
| Henan Province People's Hospital | Zhengzhou | Kína | Toborzás még nem indult |
| Xihua County People's Hospital | Zhoukou | Kína | Toboroz |
Kapcsolódó publikációk
- Safety and Efficacy of Remote Ischaemic Conditioning for Acute Ischaemic Stroke Treated with Mechanical Thrombectomy (RECAST-MT): rationale and design.Stroke Vasc Neurol · 2026 · PMID 41290408
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