Predictive Value of Contrast Volume to Creatinine Clearance Ratio (PRECOMIN)
This study is currently recruiting participants.
Verified August 2012 by Guangdong General Hospital
Sponsor:
Guangdong General Hospital
Collaborators:
Hainan People's Hospital
Guangdong Medical College
Information provided by (Responsible Party):
Jiyan Chen, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01400295
First received: July 21, 2011
Last updated: August 29, 2012
Last verified: August 2012
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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 |
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
| Estimated Enrollment: | 5000 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (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: | 21 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400295
Contacts
| Contact: Jiyan Chen, MD | 86-20-83827812-10528 | chenjiyandr@126.com |
| Contact: Yingling Zhou, MD | 86-20-83827812-10520 | gdhzyl@yahoo.com.cn |
Locations
| China, Guangdong | |
| Guangdong Cardiovascular Institute,Guangdong General Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510080 | |
| Contact: Jiyan Chen, MD 86-20-83827812-10528 chenjiyandr@126.com | |
| Contact: Yong Liu, MD 8615920172292 liuyongyisheng@126.com | |
| Principal Investigator: Yingling Zhou, MD | |
| Principal Investigator: Ning Tan, MD | |
| Principal Investigator: Jianfang Luo, MD | |
| Principal Investigator: Zhujun Chen, MD | |
| Sub-Investigator: Keng Wu, MD | |
| Sub-Investigator: Chunyan Jian, MD | |
| Sub-Investigator: Yao Dong, MD | |
Sponsors and Collaborators
Guangdong General Hospital
Hainan People's Hospital
Guangdong Medical College
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: | August 29, 2012 |
| 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 |
ClinicalTrials.gov processed this record on June 18, 2013