Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596603
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Contrast-Associated Nephropathy Risk Evaluation in Acute Ischemic Stroke After Endovascular Thrombectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CAN-REST Contrast-Associated Nephropathy Risk Evaluation in Acute Ischemic Stroke After Endovascular Thrombectomy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAN-REST
Brief Summary:
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
Detailed Description:
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 studys 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
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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None