CINPRECISENCT07020130
Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI (PRECISE)
An observational study of CIN, run by Kaiyang Lin at 1 site in China.
Trial summary
A prospective observational study included all patients undergoing percutaneous coronary intervention(PCI) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in patients undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIN
- How many people
- 3,030 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2012to 31 Dec 2018
- 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 Critically ill patients undergoing PCI at ICU were enrolled
Who may be able to join
- Critically ill patients undergoing PCI at ICU
Who cannot join
- pregnancy lactation end-stage renal disease (eGFR <15 mL/min/1.73 m2) long-term dialysis treatment intravascular administration of contrast medium within the last 7 or 3 days postoperatively
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors,PREvention and outComes for Contrast-Induced Acute Kidney Injury in patientS undErgoing Percutaneous Coronary Intervention：a Single-center Cohort Study(PRECISE)
A prospective observational study included all patients undergoing percutaneous coronary intervention(PCI) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in patients undergoing PCI.
- Conditions
- CIN
What is being measured
The primary outcome is the main question the study is designed to answer.
CI-AKI
This was due to acute kidney injury following the use of intravascular contrast media. Serum creatinine is the primary measuring modalities.
Measured: 5 year
CKD
Chronic renal structural and functional disorders that occurred during follow-up after administration of intravascular contrast agents, estimated glomerular filtration rate (eGFR) as the primary measuring modalities.
Measured: 5 year
Secondary outcomes (1)
all-cause mortality
Defined as deaths occurring during follow-up after discharge from EPCI, excluding force majeure factors such as natural disasters and car accidents,and the necessary information was gathered during follow-up.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jan 2012
- Primary completion1 Jan 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CINStudies 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
- 3,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiyang Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaiyang Lin, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020130
- Sponsor's protocol ID
- K2019-07-011
- Acronym
- PRECISE
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors,PREvention and outComes for Contrast-Induced Acute Kidney Injury in patientS undErgoing Percutaneous Coronary Intervention：a Single-center Cohort Study(PRECISE)
- ClinicalTrials.gov ID
- NCT07020130
- Acronym / sponsor ID
- PRECISE / K2019-07-011
- Conditions
- CIN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,030 participants (actual)
- Lead sponsor
- Kaiyang LinUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Jun 2025 (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.
A prospective observational study included all patients undergoing percutaneous coronary intervention(PCI) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in patients undergoing PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Critically ill patients undergoing PCI at ICU were enrolled
Key inclusion criteria (1 listed)
- Critically ill patients undergoing PCI at ICU
Key exclusion criteria (1 listed)
- pregnancy lactation end-stage renal disease (eGFR <15 mL/min/1.73 m2) long-term dialysis treatment intravascular administration of contrast medium within the last 7 or 3 days postoperatively
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
CI-AKI
Time frame: 5 year
This was due to acute kidney injury following the use of intravascular contrast media. Serum creatinine is the primary measuring modalities.
CKD
Time frame: 5 year
Chronic renal structural and functional disorders that occurred during follow-up after administration of intravascular contrast agents, estimated glomerular filtration rate (eGFR) as the primary measuring modalities.
1 secondary outcome
all-cause mortality
Time frame: 5 year
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 13 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 CIN, run by Kaiyang Lin 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Jun 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?
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?
CI-AKI (time frame: 5 year). The study lists 2 primary outcomes in all. 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 13 Jun 2025.