PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio (PRECOMIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiyan Chen, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01400295
First received: July 21, 2011
Last updated: September 14, 2014
Last verified: September 2014
  Purpose

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


Condition
Contrast Induced Nephropathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • Contrast-Induced Nephropathy [ Time Frame: 48-72 h ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • An early abnormal increase in serum creatinine [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    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

  • Major adverse clinical events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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

  • Major adverse clinical events [ Time Frame: 1month ] [ Designated as safety issue: Yes ]
    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

  • An early abnormal increase in serum cystatin C [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
    An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure


Enrollment: 3000
Study Start Date: December 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
coronary angiography
The investigators reviewed all consecutive patients who were undergoing 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The investigators reviewed all consecutive patients who were undergoing coronary angiography

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400295

Locations
China, Guangdong
Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Study Chair: Jiyan Chen, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yong Liu, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Yingling Zhou, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Study Director: Ning Tan, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Principal Investigator: Jianfang Luo, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01400295     History of Changes
Other Study ID Numbers: 20100917
Study First Received: July 21, 2011
Last Updated: September 14, 2014
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
contrast-induced nephropathy
contrast medium
creatinine clearance
coronary angiography
diabetes
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2014