NCT Number: NCT02664246
Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method
This review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors.
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Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
About this study
About ten thousand patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015 are included in this study. We collect the data about the SCr of the patients before and after percutaneous coronary intervention, and define CIN as an increase in SCr of 0.5 mg/dl or 25% from baseline between 48 and 72 h after contrast medium exposure. Besides we obtain the data including clinical characteristics, laboratory data (blood and urine tests) for all the patients. The statistical analysis will find some new risk factors.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
- moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
- patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.
Exclusion criteria
- hemodialysis-dependent patients;
- complicated with severe short-term progressive disease;
- Patients < 18 years;
- pregnancy;
- emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
- exposure to radiographic contrast media within the previous 7 days;
- acute decompensated heart failure.
Treatment and study plan
Primary outcomes
-
Contrast induced nephropathy postoperation
Time frame: 7 days
peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
Secondary outcomes
-
Composite measure of dialysis or main cardiovascular events
Time frame: 90 days
dialysis, myocardial infarction, heart failure and all-cause death
Sponsors and collaborators
Lead sponsor
Chinese PLA General Hospital
Other
Registry information
Official study title
Chinese People's Liberation Army General Hospital
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jan 27, 2016
- Registry last updated
- Jan 27, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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