Clinical trial NCT01400295: PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio
Official title: Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Induced Nephropathy
Keywords: contrast-induced nephropathy
contrast medium
creatinine clearance
coronary angiography
diabetes
chronic kidney disease
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators reviewed all consecutive patients who were undergoing coronary angiography

Brief summary: To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography

Detailed description: Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance \< 60 ml/min,diabetes,emergent angiography.

Eligibility criteria: Inclusion Criteria:

* patients who agreed to stay in the hospital for 2-3 days after coronary angiography
* provided written informed consent

Exclusion Criteria:

* pregnancy
* lactation
* intravascular administration of an contrast medium within the previous seven days
* treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),nonsteroidal anti-inflammatory drugs within the previous 48 h
* intake of nephrotoxic drugs within the previous seven days
* history of serious reactions to contrast mediums， severe concomitant disease renal transplantation , or end-stage renal disease necessitating dialysis
* patients who died during coronary angiography

Primary outcomes:
measure: Contrast-Induced Nephropathy
timeFrame: 48-72 h
Secondary outcomes:
measure: An early abnormal increase in serum creatinine
timeFrame: 24h
measure: Major adverse clinical events
timeFrame: 1 year
measure: Major adverse clinical events
timeFrame: 1month
measure: An early abnormal increase in serum cystatin C
timeFrame: 24h
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Cardiovascular Institute,Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Jiyan Chen, MD
role: STUDY_CHAIR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Yong Liu, MD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Yingling Zhou, MD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Ning Tan, MD
role: STUDY_DIRECTOR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Jianfang Luo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu L, Liu J, Lei L, Wang B, Sun G, Guo Z, He Y, Song F, Lun Z, Liu B, Chen G, Chen S, Yang Y, Liu Y, Chen J. A prediction model of contrast-associated acute kidney injury in patients with hypoalbuminemia undergoing coronary angiography. BMC Cardiovasc Disord. 2020 Aug 31;20(1):399. doi: 10.1186/s12872-020-01689-6.
citation: Liu Y, Chen S, Ye J, Xian Y, Wang X, Xuan J, Tan N, Li Q, Chen J, Ni Z. Random forest for prediction of contrast-induced nephropathy following coronary angiography. Int J Cardiovasc Imaging. 2020 Jun;36(6):983-991. doi: 10.1007/s10554-019-01730-6. Epub 2020 Apr 13.
citation: Liu J, Sun G, He Y, Song F, Chen S, Guo Z, Liu B, Lei L, He L, Chen J, Tan N, Liu Y. Early beta-blockers administration might be associated with a reduced risk of contrast-induced acute kidney injury in patients with acute myocardial infarction. J Thorac Dis. 2019 Apr;11(4):1589-1596. doi: 10.21037/jtd.2019.04.65.
citation: Guo XS, Chen SQ, Duan CY, Li HL, Bei WJ, Liu Y, Tan N, Chen PY, Chen JY. Association of post-procedural early (within 24h) increases in serum creatinine with all-cause mortality after coronary angiography. Clin Chim Acta. 2017 Nov;474:96-101. doi: 10.1016/j.cca.2017.08.036. Epub 2017 Sep 1.