NCT06596603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1.8 years

First QC Date

August 28, 2024

Last Update Submit

July 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive EVT-treated acute ischemic stroke patients discharged at the participating centers from 1 January 2023 to 31 December 2023.

To be eligible to participate in this study, subjects must meet all of the following criteria: * Age \>18 years at the time of AIS * Documented serum creatinine: * pre-EVT and * within 48h and/or within 7 days after EVT. Patients on chronic dialysis will be collected but excluded from the analyses

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2024

First Posted

September 19, 2024

Study Start

March 1, 2023

Primary Completion

December 31, 2024

Study Completion

July 1, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations