- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07020130
- Original Trial
Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI (PRECISE) (PRECISE)
June 5, 2025 updated by: Kaiyang Lin
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
3030
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fujian
-
Fuzhou,, Fujian, China, China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All Critically ill patients undergoing PCI at ICU were enrolled
Description
Inclusion Criteria:
- Critically ill patients undergoing PCI at ICU
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 year
|
|
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.
|
5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
all-cause mortality
Time Frame: 5 year
|
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.
|
5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2012
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
May 26, 2025
First Submitted That Met QC Criteria
June 5, 2025
First Posted (Actual)
June 13, 2025
Study Record Updates
Last Update Posted (Actual)
June 13, 2025
Last Update Submitted That Met QC Criteria
June 5, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- K2019-07-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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