Clinical trial NCT02664246: Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method
Official title: Chinese People's Liberation Army General Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardio-Renal Syndrome
Keywords: contrast-induced nephropathy
Percutaneous coronary intervention
risk factors
incidence
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Contrast induced nephropathy postoperation
timeFrame: 7 days
Secondary outcomes:
measure: Composite measure of dialysis or main cardiovascular events
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: Dai Yun Chen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.