Contrast-Associated Acute Kidney InjuryCAN-RESTNCT06596603
Contrast-Associated Nephropathy Risk Evaluation in Acute Ischemic Stroke After Endovascular Thrombectomy
An observational study of Contrast-Associated Acute Kidney Injury, run by Niguarda Hospital at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-Associated Acute Kidney Injury
- How many people
- 8,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAN-REST: Contrast-Associated Nephropathy Risk Evaluation in Acute Ischemic Stroke After Endovascular Thrombectomy
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.
Read the 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 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.
- Conditions
- Contrast-Associated Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 48 hours and up to 7 days post-endovascular thrombectomy.
Secondary outcomes (4)
Days of In-Hospital Stay
Measure the total number of days patients remain hospitalized following endovascular thrombectomy
Measured: 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])
Assess the level of disability or dependence in daily activities of patients post-stroke, measured at discharge and at 90 days post-procedure
Measured: 90 days post-procedure
All-Cause Mortality at 90 Days (modified Rankin Scale, mRS = 6)
Measure the number of deaths from any cause within 90 days following endovascular thrombectomy Time Frame: 90 days post-procedure.
Measured: 90 days post-procedure
Development of Risk Stratification Tools
Create and validate predictive models for CA-AKI using baseline and EVT-related variables to categorize patients into risk groups (low, medium, high)
Measured: 24 hours, 48 hours, at 3 months, and at 12 months post-endovascular thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast-Associated Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596603
- Sponsor's protocol ID
- 4658_17.04.2024_N
- Acronym
- CAN-REST
- Status last verified
- Jul 2025
- First submitted
- 28 Aug 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwarz G, Cascio Rizzo A, Ambler G, Wrona P, Slowik A, Bodzioch A, Doheim MF, Al-Bayati AR, Nogueira RG, Nunes AP, Ferreira P, Paolucci M, Zini A, Simonetti L, Lesko N, Fedorko J, Gdovinova Z, Scarcia L, Kalsoum E, Farhat F, Beyeler M, Mujanovic A, Arnold M, Meira T, Morais M, Francisco L, Wiacek M, Pudlo P, Bartosik-Psujek H, Calleja P, Ostos F, Seoane D, Anca N, Radu RA, Tiu C, Al Kasab S, Abu Qdais A, Samman Tahhan I, Ayo-Martin O, Hernandez-Fernandez F, Paya M, Molina-Nevo JD, Labuz-Roszak BM, Toni D, Moszko K, Roszak ML, De Michele M, Barrile E, Eswaradass P, Houghton ML, Barkley T, Ali A, Demeestere J, Bauknight WM, Sheth SA, Maes L, Wouters A, Marto JP, Costa JB, Loizzo ND, Romi A, Curro CT, Luchowski P, Seweryn M, Rejdak K, Klein P, Abdalkader M, Saia V, Sanna A, Tassinari T, Acampa M, Rosini F, Tassi R, Bilik ME, Bandzarewicz-Samcik AM, Min J, HajAissa N, Mangiardi M, Anticoli S, Pampana E, Hervas-Testal C, Rigual R, Fuentes B, Strambo D, Tetaria CM, Saliou G, Caramma AS, Maimone D, Rizzo PA, Moci M, Scala I, Cruz-Culebras A, Vera Lechuga R, Garcia Madrona S, Merlino G, Valente M, Todesco A, Bolognese M, Lakatos LB, Karwacki GM, Candelaresi P, Andreone V, Maurea C, Tarletti R, Mele A, Ciacciarelli A, Alessiani M, Monteforte G, Pakizer D, Roubec M, Skoloudik D, Vandervorst F, De Raedt S, Verdam M, Bartos J, Sramek M, Mazzoleni V, Quilici L, Alimonti D, Moller J, Maestrini I, Diomedi M, Lacidogna G, Zaidat OO, Lin E, AlMajali M, Baracchini C, Zaccagnino M, Viaro F, Pezzini A, Avola G, Ferraro C, Switonska M, Sobieszak-Skura P, Meder G, Mayer-Suess L, Knoflach M, Gizewski ER, Common MR, Nicholson P, Power S, Nowakowska-Kotas MM, Pula M, Guzinski M, Perez Sanchez S, Montaner J, Sevilla Bravo A, Marcheselli S, Vodret F, Rapillo C, Pereira L, Rodrigues M, Jaros A, Kovar M, Vojik J, Valcamonica G, Gallo Cassarino S, Cardillo A, Petruzzellis M, Grimaldi S, Marrone N, Hassan AE, Miller S, Khasawneh MW, Poretto V, Tonello S, Tollot S, Debiec A, Staszewski J, Stepien A, Bernardo F, Ferrao J, Zedde M, Pascarella R, Sanna A, Meloni R, Delibas K, Sacco S, Vittorini MG, Ornello R, Mannino M, Terruso V, Filizzolo M, Hall E, Roffe C, Dorobek M, Zielinska-Turek J, Scopelliti G, Pantoni L, Pero GC, Macera A, Cervo A, Bellavia S, Longoni M, Sezgin M, Dilmen Y, Ekizoglu E, Tsivgoulis G, Theodorou A, Tiu VE, Panea CA, Petrescu S, Piano M, Nguyen TN, Sessa M. Beyond the Threshold: Continuous Creatinine Change and Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke. Stroke. 2026 Oct 1. doi: 10.1161/STROKEAHA.126.056847. Online ahead of print.
PubMed 42817886
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAN-REST: Contrast-Associated Nephropathy Risk Evaluation in Acute Ischemic Stroke After Endovascular Thrombectomy
- ClinicalTrials.gov ID
- NCT06596603
- Acronym / sponsor ID
- CAN-REST / 4658_17.04.2024_N
- Conditions
- Contrast-Associated Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive EVT-treated acute ischemic stroke patients discharged at the participating centers from 1 January 2023 to 31 December 2023.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI)
Time frame: 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.
4 secondary outcomes
Days of In-Hospital Stay
Time frame: 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])
Time frame: 90 days post-procedure
All-Cause Mortality at 90 Days (modified Rankin Scale, mRS = 6)
Time frame: 90 days post-procedure
Development of Risk Stratification Tools
Time frame: 24 hours, 48 hours, at 3 months, and at 12 months post-endovascular thrombectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 42817886Schwarz G, Cascio Rizzo A, Ambler G, Wrona P, Slowik A, Bodzioch A, Doheim MF, Al-Bayati AR, Nogueira RG, Nunes AP, Ferreira P, Paolucci M, Zini A, Simonetti L, Lesko N, Fedorko J, Gdovinova Z, Scarcia L, Kalsoum E, Farhat F, Beyeler M, Mujanovic A, Arnold M, Meira T, Morais M, Francisco L, Wiacek M, Pudlo P, Bartosik-Psujek H, Calleja P, Ostos F, Seoane D, Anca N, Radu RA, Tiu C, Al Kasab S, Abu Qdais A, Samman Tahhan I, Ayo-Martin O, Hernandez-Fernandez F, Paya M, Molina-Nevo JD, Labuz-Roszak BM, Toni D, Moszko K, Roszak ML, De Michele M, Barrile E, Eswaradass P, Houghton ML, Barkley T, Ali A, Demeestere J, Bauknight WM, Sheth SA, Maes L, Wouters A, Marto JP, Costa JB, Loizzo ND, Romi A, Curro CT, Luchowski P, Seweryn M, Rejdak K, Klein P, Abdalkader M, Saia V, Sanna A, Tassinari T, Acampa M, Rosini F, Tassi R, Bilik ME, Bandzarewicz-Samcik AM, Min J, HajAissa N, Mangiardi M, Anticoli S, Pampana E, Hervas-Testal C, Rigual R, Fuentes B, Strambo D, Tetaria CM, Saliou G, Caramma AS, Maimone D, Rizzo PA, Moci M, Scala I, Cruz-Culebras A, Vera Lechuga R, Garcia Madrona S, Merlino G, Valente M, Todesco A, Bolognese M, Lakatos LB, Karwacki GM, Candelaresi P, Andreone V, Maurea C, Tarletti R, Mele A, Ciacciarelli A, Alessiani M, Monteforte G, Pakizer D, Roubec M, Skoloudik D, Vandervorst F, De Raedt S, Verdam M, Bartos J, Sramek M, Mazzoleni V, Quilici L, Alimonti D, Moller J, Maestrini I, Diomedi M, Lacidogna G, Zaidat OO, Lin E, AlMajali M, Baracchini C, Zaccagnino M, Viaro F, Pezzini A, Avola G, Ferraro C, Switonska M, Sobieszak-Skura P, Meder G, Mayer-Suess L, Knoflach M, Gizewski ER, Common MR, Nicholson P, Power S, Nowakowska-Kotas MM, Pula M, Guzinski M, Perez Sanchez S, Montaner J, Sevilla Bravo A, Marcheselli S, Vodret F, Rapillo C, Pereira L, Rodrigues M, Jaros A, Kovar M, Vojik J, Valcamonica G, Gallo Cassarino S, Cardillo A, Petruzzellis M, Grimaldi S, Marrone N, Hassan AE, Miller S, Khasawneh MW, Poretto V, Tonello S, Tollot S, Debiec A, Staszewski J, Stepien A, Bernardo F, Ferrao J, Zedde M, Pascarella R, Sanna A, Meloni R, Delibas K, Sacco S, Vittorini MG, Ornello R, Mannino M, Terruso V, Filizzolo M, Hall E, Roffe C, Dorobek M, Zielinska-Turek J, Scopelliti G, Pantoni L, Pero GC, Macera A, Cervo A, Bellavia S, Longoni M, Sezgin M, Dilmen Y, Ekizoglu E, Tsivgoulis G, Theodorou A, Tiu VE, Panea CA, Petrescu S, Piano M, Nguyen TN, Sessa M. Beyond the Threshold: Continuous Creatinine Change and Outcomes After Endovascular Thrombectomy for Acute Ischemic Stroke. Stroke. 2026 Oct 1. doi: 10.1161/STROKEAHA.126.056847. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast-Associated Acute Kidney Injury, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Contrast-Associated Acute Kidney Injury (CA-AKI) (time frame: Within 48 hours and up to 7 days post-endovascular thrombectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.