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CompletedNCT01400295PRECOMINUpdated Sep 16, 2014

PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio

An observational study in Contrast Induced Nephropathy, sponsored by Guangdong Provincial People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-16.

Sponsored by Guangdong Provincial People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

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Conditions studied

  • Contrast Induced Nephropathy

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Keywords

  • contrast-induced nephropathy
  • contrast medium
  • creatinine clearance
  • coronary angiography
  • diabetes
  • chronic kidney disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 3,000 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The investigators reviewed all consecutive patients who were undergoing coronary angiography

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (actual)
Patient registry
No

Groups and cohorts

  • coronary angiography

    The investigators reviewed all consecutive patients who were undergoing coronary angiography

06

What researchers measure

Primary outcomes

  1. Contrast-Induced Nephropathy

    Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure

    Time frame: 48-72 h

Secondary outcomes

  1. An early abnormal increase in serum creatinine

    An early abnormal increase in serum creatinine defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 24h of contrast exposure

    Time frame: 24h

  2. Major adverse clinical events

    Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke

    Time frame: 1 year

  3. Major adverse clinical events

    Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke

    Time frame: 1month

  4. An early abnormal increase in serum cystatin C

    An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure

    Time frame: 24h

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Study locations

1 site
  • Guangdong Cardiovascular Institute,Guangdong General Hospital
    Guangzhou, Guangdong 510080, China
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References and documents

Publications

  • 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. PubMed 32867690 ↗
  • 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. PubMed 32285318 ↗
  • 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. PubMed 31179103 ↗
  • 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. PubMed 28866117 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01400295
Lead sponsor
Guangdong Provincial People's Hospital
Responsible party
Jiyan Chen (MD, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Jul 22, 2011
Start date
Dec 2010
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Sep 16, 2014

Study contacts

Jiyan Chen, MD
study chair · Guangdong Cardiovascular Institute,Guangdong General Hospital
Yong Liu, MD
study director · Guangdong Cardiovascular Institute,Guangdong General Hospital
Yingling Zhou, MD
study director · Guangdong Cardiovascular Institute,Guangdong General Hospital
Ning Tan, MD
study director · Guangdong Cardiovascular Institute,Guangdong General Hospital
Jianfang Luo, MD
principal investigator · Guangdong Cardiovascular Institute,Guangdong General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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