跳至主要内容
临床试验/NCT06596603
NCT06596603已完成不适用

CAN-REST: Contrast-Associated Nephropathy Risk Evaluation in Acute Ischemic Stroke After Endovascular Thrombectomy

Niguarda Hospital1 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8,000
试验地点
1
主要终点
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)

研究概览

简要总结

The CAN-REST study is a multicenter, observational, and retrospective study aimed at evaluating the incidence and risk factors of contrast-associated acute kidney injury (CA-AKI) in patients with acute ischemic stroke (AIS) who undergo endovascular thrombectomy (EVT). This study is conducted across multiple centers in Italy, Europe, the USA, and Canada, and includes data from AIS patients treated with EVT in 2023. The primary objectives are to assess the incidence of CA-AKI in this population and identify associated risk factors. Secondary objectives include evaluating the impact of CA-AKI on clinical outcomes, such as the length of hospital stay, functional recovery, and 90-day mortality, as well as developing risk stratification tools to predict CA-AKI. By analyzing a large cohort of patients, CAN-REST aims to provide critical insights into the renal complications associated with EVT and establish predictive models that can guide clinical decision-making and improve patient outcomes.

详细描述

The CAN-REST study is a multicenter, observational, and retrospective study designed to evaluate the incidence and risk factors of contrast-associated acute kidney injury (CA-AKI) in patients who have suffered an acute ischemic stroke (AIS) and subsequently underwent endovascular thrombectomy (EVT). The use of contrast agents during EVT, essential for visualizing blood vessels and guiding the procedure, poses a risk for CA-AKI, particularly in patients who are already in a vulnerable state due to stroke-related comorbidities and the acute nature of their condition.

The primary objective of the study is to assess the incidence of CA-AKI in AIS patients following EVT and to identify specific risk factors that contribute to the development of CA-AKI. Secondary objectives include evaluating the impact of CA-AKI on clinical outcomes, such as the length of hospital stay, functional recovery as measured by the modified Rankin Scale (mRS) at discharge and 90 days post-procedure, and all-cause mortality at 90 days. Additionally, the study aims to develop and validate risk stratification tools that can predict the likelihood of CA-AKI based on both baseline patient characteristics and procedural variables related to EVT.

The study population consists of all consecutive AIS patients treated with EVT in participating centers from January 1, 2023, to December 31, 2023. Data collection will include detailed information on patient demographics, clinical history, stroke severity, procedural details of EVT, and subsequent renal function assessments to determine the development of CA-AKI. Two predictive models will be developed: one using only pre-EVT variables and another incorporating EVT-related variables to better stratify patients according to their risk for developing CA-AKI.

By analyzing a large cohort of patients from multiple centers worldwide, CAN-REST aims to provide valuable insights into the renal complications associated with the use of contrast media in EVT for AIS patients. The study's findings are expected to guide clinical practice by identifying high-risk patients and enabling the development of preventative strategies, ultimately improving patient outcomes and care standards in stroke treatment.

研究设计

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

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)

时间窗: Within 48 hours and up to 7 days post-endovascular thrombectomy.

Measure the occurrence of acute kidney injury characterized by an increase in serum creatinine ≥0.3 mg/dL or ≥50% within 48 hours, or an increase of ≥0.3 mg/dL within 7 days post-endovascular thrombectomy in acute ischemic stroke patients.

次要结局

  • Days of In-Hospital Stay(Measured daily from hospital admission until the day of discharge post-endovascular thrombectomy, assessed up to 30 days)
  • Functional Recovery (modified Rankin Scale, mRS; ranging from 0 [full recovery] to 6[death])(90 days post-procedure)
  • All-Cause Mortality at 90 Days (modified Rankin Scale, mRS = 6)(90 days post-procedure)
  • Development of Risk Stratification Tools(24 hours, 48 hours, at 3 months, and at 12 months post-endovascular thrombectomy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Contrast-Associated Nephropathy Risk Evaluation in... | 临床试验