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CompletedNCT02664246Updated Jan 27, 2016

Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method

An observational study in Cardio-Renal Syndrome, sponsored by Chinese PLA General Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-27.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
10,000
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Cardio-Renal Syndrome

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Keywords

  • contrast-induced nephropathy
  • Percutaneous coronary intervention
  • risk factors
  • incidence
03

In context

Cardio-Renal Syndrome

76 studies on the registry are indexed under Cardio-Renal Syndrome; 22 are open to participants now.

This study's enrollment of 10,000 is above the median of 150 across 26 observational studies indexed under Cardio-Renal Syndrome.

Browse Cardio-Renal Syndrome studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 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 to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015

Inclusion criteria

  1. congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) \<= 50%;
  2. 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;
  3. patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.

Exclusion criteria

Exclusion Criteria:

  1. hemodialysis-dependent patients;
  2. complicated with severe short-term progressive disease;
  3. Patients \< 18 years;
  4. pregnancy;
  5. emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
  6. exposure to radiographic contrast media within the previous 7 days;
  7. acute decompensated heart failure.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
10,000 participants (actual)
Patient registry
No

Interventions

  • Devicepercutaneous coronary intervention
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What researchers measure

Primary outcomes

  1. Contrast induced nephropathy postoperation

    peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7

    Time frame: 7 days

Secondary outcomes

  1. Composite measure of dialysis or main cardiovascular events

    dialysis, myocardial infarction, heart failure and all-cause death

    Time frame: 90 days

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Tao SM, Wichmann JL, Schoepf UJ, Fuller SR, Lu GM, Zhang LJ. Contrast-induced nephropathy in CT: incidence, risk factors and strategies for prevention. Eur Radiol. 2016 Sep;26(9):3310-8. doi: 10.1007/s00330-015-4155-8. Epub 2015 Dec 18. PubMed 26685852 ↗
  • Wichmann JL, Katzberg RW, Litwin SE, Zwerner PL, De Cecco CN, Vogl TJ, Costello P, Schoepf UJ. Contrast-Induced Nephropathy. Circulation. 2015 Nov 17;132(20):1931-6. doi: 10.1161/CIRCULATIONAHA.115.014672. No abstract available. PubMed 26572669 ↗
  • Andreucci M, Faga T, Pisani A, Sabbatini M, Russo D, Michael A. Prevention of contrast-induced nephropathy through a knowledge of its pathogenesis and risk factors. ScientificWorldJournal. 2014;2014:823169. doi: 10.1155/2014/823169. Epub 2014 Nov 30. PubMed 25525625 ↗
  • Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9. PubMed 26685074 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2016, 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
NCT02664246
Lead sponsor
Chinese PLA General Hospital
Responsible party
Qian geng (associate chief physician, Chinese PLA General Hospital) — Principal investigator
First posted
Jan 27, 2016
Start date
Jan 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jan 27, 2016

Study contacts

Dai Yun Chen, MD
study chair · Chinese PLA General Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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