PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio

Contrast Induced Nephropathy Clinical Trial

— PRECOMIN  

Official title:

Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400295
• Other study ID #: 20100917
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: September 14, 2014
• Start date: December 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2014
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Locations

Country	Name	City	State
China	Guangdong Cardiovascular Institute,Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48-72 h	Yes
Secondary	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	24h	Yes
Secondary	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	1 year	Yes
Secondary	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	1month	Yes
Secondary	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	24h	Yes