Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive StrategyNCT06491953
SGLT2-inhibitors on PC-AKI
An observational study of Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy, run by Shenyang Northern Hospital at 1 site in China.
Trial summary
Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy
- What is being tested?
- SGLT-2 inhibitors
- How many people
- 3,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 28 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACS patients aged 18-80 years old receiving invasive treatment were enrolled.
Who may be able to join
- ACS patients undergoing invasive treatment (PCI or CAG)
- 18 ~ 80 years old adult patients
- Written informed consent provided
Who cannot join
- Administration of any iodinated CM within 14 days before CAG or PCI
- Hepatic dysfunction (ALT 3 times greater than upper normal limit)
- Thyreoid insufficiency
- Renal artery Stenosis (unilateral >70％ or bilateral stenosis>50％)
- Known allergy to any of the study drugs or devices (iodinated CM, etc.)
- Pregnancy or lactation
- Contraindications for the use of SGLT-2 inhibitors, such as severe renal insufficiency (eGFR <30 mL/min/1.73m2 or currently on dialysis), type 1 diabetes mellitus, severe infection, etc.)
- Any condition which might interfere with study compliance, or otherwise unsuitable for study participation as judged by the investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy
Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI).
Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR).
Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.
- Being tested
- SGLT-2 inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorsDrug
SGLT-2 inhibitors use or not use； the duration of SGLT-2 inhibitors use
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving invasive treatment | Patients receiving PCI or CAG were enrolled to evaluate the impact of SGLT-2 inhibitors use or not use and duration of SGLT-2 inhibitors administration Receives: Drug: SGLT-2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post contrast acute kidney injury (PC-AKI)
PC-AKI was defined by the European Society of Genitourinary Radiology (EUSR): increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline
Measured: 48 hours after procedure
Secondary outcomes (2)
Major adverse cardiovascular and cerebrovascular events(MACCE)
Cardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization
Measured: up to 12 months
All-cause mortality
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jun 2024
- Primary completion30 May 2025
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive StrategyStudies 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
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491953
- Sponsor's protocol ID
- TIMING-AKI V1.0
- Status last verified
- Sep 2025
- First submitted
- 1 Jul 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SGLT2-inhibitors on Post Contrast Acute Kidney Injury in Acute Coronary Syndrome Patients Receiving Invasive Strategy
- ClinicalTrials.gov ID
- NCT06491953
- Acronym / sponsor ID
- TIMING-AKI V1.0
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 9 Jul 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.
Percutaneous coronary intervention (PCI) is one of the most common invasive strategies employed in the diagnosis and treatment of coronary artery disease (CAD) patients. Invasive procedures necessitate the use of iodine-based contrast agents, which could lead to post contrast acute kidney injury (PC-AKI).
Sodium-glucose cotransporter 2 (SGLT-2) inhibitors, as a class of oral antidiabetic medications, function by inhibiting SGLT-2, preventing the reabsorption of filtered glucose by the kidneys and thereby increasing glucose excretion in urine. In recent years, a series of studies including EMPA-REG OUTCOME, CREDENCE, DAPA-CKD, DECLARE-TIMI 58, and the CANVAS program have consistently demonstrated that SGLT-2 inhibitors not only effectively improve renal function and slow the progression of chronic kidney disease (CKD), but also significantly reduce the risk of cardiovascular adverse events. Nevertheless, due to their osmotic diuretic effect, SGLT-2 inhibitors can lead to a reduction in renal blood volume within the early phase of application (within two weeks), temporarily augmenting the renal workload and resulting in a decrease in estimated glomerular filtration rate (eGFR).
Consequently, there remains a need to ascertain the specific role of SGLT-2 inhibitors in the prevention of PC-AKI and provide evidence-based support for their application in this context.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving invasive treatment | – | Drug: SGLT-2 inhibitorsPatients receiving PCI or CAG were enrolled to evaluate the impact of SGLT-2 inhibitors use or not use and duration of SGLT-2 inhibitors administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACS patients aged 18-80 years old receiving invasive treatment were enrolled.
Key inclusion criteria (3 listed)
- ACS patients undergoing invasive treatment (PCI or CAG)
- 18 ~ 80 years old adult patients
- Written informed consent provided
Key exclusion criteria (8 listed)
- Administration of any iodinated CM within 14 days before CAG or PCI
- Hepatic dysfunction (ALT 3 times greater than upper normal limit)
- Thyreoid insufficiency
- Renal artery Stenosis (unilateral >70％ or bilateral stenosis>50％)
- Known allergy to any of the study drugs or devices (iodinated CM, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitorsSGLT-2 inhibitors use or not use； the duration of SGLT-2 inhibitors use | Drug | Patients receiving invasive treatment |
Primary outcome
Incidence of Post contrast acute kidney injury (PC-AKI)
Time frame: 48 hours after procedure
PC-AKI was defined by the European Society of Genitourinary Radiology (EUSR): increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline
2 secondary outcomes
Major adverse cardiovascular and cerebrovascular events(MACCE)
Time frame: up to 12 months
All-cause mortality
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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 Impact of SGLT2-inhibitors on PC-AKI in ACS Patients Receiving Invasive Strategy, run by Shenyang Northern Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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 Post contrast acute kidney injury (PC-AKI) (time frame: 48 hours after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.