PRECOMIN: PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| coronary angiography The investigators reviewed all consecutive patients who were undergoing coronary angiography |
Outcome Measures
Primary Outcome Measures
- Contrast-Induced Nephropathy [48-72 h]
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 [24h]
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 [1 year]
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 [1month]
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 [24h]
An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure
Eligibility Criteria
Criteria
Inclusion Criteria:
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patients who agreed to stay in the hospital for 2-3 days after coronary angiography
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provided written informed consent
Exclusion Criteria:
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pregnancy
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lactation
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intravascular administration of an contrast medium within the previous seven days
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treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),nonsteroidal anti-inflammatory drugs within the previous 48 h
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intake of nephrotoxic drugs within the previous seven days
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history of serious reactions to contrast mediums， severe concomitant disease renal transplantation , or end-stage renal disease necessitating dialysis
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patients who died during coronary angiography
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangdong Cardiovascular Institute,Guangdong General Hospital | Guangzhou | Guangdong | China | 510080 |
Sponsors and Collaborators
- Guangdong Provincial People's 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20100917