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Completed

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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Key information

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

Percutaneous coronary intervention

Device

Primary outcomes

  1. 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

  1. 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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