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临床试验/NCT05578300
NCT05578300招募中不适用

Effective Translation of Endovascular Thrombectomy Trials Into Real-world Practice in the Asia-Pacific: a Multicenter, Prospective Registry (ENDURE-APAC)

Chinese University of Hong Kong3 个研究点 分布在 2 个国家目标入组 350 人开始时间: 2022年10月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
3
主要终点
Pre-morbid functional status assessed by modified Rankin Scale (mRS)

研究概览

简要总结

As a major breakthrough of acute stroke treatment over the past decade, endovascular thrombectomy (EVT) drastically improved neurological recovery and survival in patients with large vessel occlusion (LVO) ischemic strokes in major clinical trials. Nevertheless, much remained uncertain about the implementation of scientific evidence of EVT into real-world benefits. For instance, healthcare policies that influence critical time-matrices, endovascular thrombectomy techniques that may enhance success rate or prevent complications, or advanced imaging techniques that allow precise prognosis or expansion of treatment populations, should be evaluated. On the other hand, capturing LVO patients who were not able to undergo EVT may reveal the gap between clinical trials and real-world practice in the Asia-Pacific.

In this multicenter prospective collaboration across the Asian-Pacific, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.

详细描述

In this multicenter, prospective, longitudinal study, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.

The investigators shall recruit patient who are over 18 years of age, with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

Detailed study procedures are as follows:

  1. As the EVT center of the New Territory East Cluster (NTEC), all patients who undergo EVT triage in the NTEC, i.e. patients with suspected LVO, would be assessed by neuro-interventionists from the Prince of Wales Hospital (PWH). Eligibility screening for recruitment under the ENDURE-APAC registry will be carried out simultaneously.

  2. The investigators shall obtain informed consent either from patient or next-of-kin. Informed consent will be obtained from his/her legal guardian or next-of-kin for those incompetent subjects who are willing to participate in the study. Subjects will be reconsented when competent.

  3. After the informed consent, a study identity number will be assigned to each participant. The investigators shall obtain the following data:

  4. Demographic data such as age, gender, date of birth, smoking and drinking habit, pre-morbid functional status (by modified Rankin Scale (mRS)).

  5. Co-morbidities including hypertension, diabetes mellitus, hyperlipidemia, atrial fibrillation, previous strokes, ischemic heart disease, peripheral vascular disease, congestive heart failure, etc.

  6. Concurrent medications including anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, heparin, warfarin), antiplatelet agents (aspirin, clopidogrel, ticagrelor, cilostazol), lipid-lowering agents (simvastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin, ezetimibe, gemfibrozil, fenofibrate, erenumab), antihypertensive (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, calcium channel blockers, diuretics, aldosterone antagonists, nitrates, etc.), cytochrome P450 or P-glycoprotein inhibitors (amiodarone, dronedarone, phenytoin, valproate, carbamazepine, levetiracetam, rifampicin, cyclosporin, etc.), non-steroidal anti-inflammatory agents or cyclo-oxygenase2 inhibitors (indomethacin, ibuprofen, diclofenac, celecoxib, etorixocib), glucose lowering drugs (metformin, gliclazide, glimepiride, empagliflozin, dapagliflozin, insulin, exenatide, semaglutide, liraglutide, dulaglutide).

  7. Radiological findings, treatment outcomes and complications (see 2.3.2 and 2.3.4.) will be documented.

  8. Baseline hemoglobin, white blood cell, platelet count, creatinine, sodium, potassium, alanine transferase, alkaline phosphatase, high density lipoprotein cholesterol, low density lipoprotein cholesterol, total cholesterol, triglyceride level, prothrombin time, activated thromboplastin time, fasting glucose, glycated hemoglobin A1c will be documented.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who are over 18 years of age.
  • Patient with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

排除标准

  • Patient with isolated vertebral artery occlusion not involving the BA.

研究组 & 干预措施

Patient with ischemic stroke with suspected large vessel occlusion

The investigators shall recruit patients that meet the following inclusion criteria:

  1. Patient who are over 18 years of age.
  2. Patient with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

干预措施: Thrombus analyses (Diagnostic Test)

Patient with ischemic stroke with suspected large vessel occlusion

The investigators shall recruit patients that meet the following inclusion criteria:

  1. Patient who are over 18 years of age.
  2. Patient with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

干预措施: Imaging assessment (Diagnostic Test)

结局指标

主要结局

Pre-morbid functional status assessed by modified Rankin Scale (mRS)

时间窗: 18 October 2032

Neurological recover and survival as assessed by mRS at 90 days, with the scale runs from 0-6, running from perfect health without symptoms (Score 0) to death (Score 6).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. IP Yiu Ming Bonaventure

Assistant Professor

Chinese University of Hong Kong

研究点 (3)

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