Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention (CONVIN)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Guangdong General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Guangdong General Hospital
Collaborators:
Hainan People's Hospital
Guangdong Medical College
Information provided by:
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01399203
First received: July 19, 2011
Last updated: August 2, 2011
Last verified: January 2010
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Purpose
To investigate the predictive value of the contrast media volume to creatinine clearance (V/CrCl) ratio for the risk of contrast-induced nephropathy (CIN) (i.e., within 48-72 h) and to determine a relatively safe V/CrCl cut-off value to avoid CIN in patients following PCI
| Condition |
|---|
|
Contrast Induced Nephropathy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention |
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:
- 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
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
percutaneous coronary intervention
The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention
|
Detailed Description:
contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after unselective PCI. 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 CIN was assessed using multivariate logistic regression.
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 percutaneous coronary intervention
Criteria
Inclusion Criteria:
- patients who agreed to stay in the hospital for 2-3 days after percutaneous coronary intervention
- provided written informed consent
- Creatinine Clearance:15-60ml/min
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 percutaneous coronary intervention
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399203
Contacts
| Contact: Ning Tan, MD | 86-20-83819161 | tanning100@126.com |
| Contact: Yong Liu, MD | 86-15920172292 | liuyongyisheng@126.com |
Locations
| China, Guangdong | |
| Ning Tan | Recruiting |
| Guangzhou, Guangdong, China, 510100 | |
| Contact: Ning Tan, MD 8620-83819161 tanning100@126.com | |
| Contact: Yong Liu, MD 8615920172292 liuyongyisheng@126.com | |
| Principal Investigator: Yong Liu, MD | |
| Principal Investigator: Jiyan Chen, MD | |
| Principal Investigator: Yingling Zhou, MD | |
| Principal Investigator: Jianfang Luo, MD | |
| Principal Investigator: Shuguang Lin, MD | |
Sponsors and Collaborators
Guangdong General Hospital
Hainan People's Hospital
Guangdong Medical College
Investigators
| Study Director: | Yong Liu, MD | Guangdong General Hospital |
More Information
No publications provided
| Responsible Party: | Ning Tan, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital |
| ClinicalTrials.gov Identifier: | NCT01399203 History of Changes |
| Other Study ID Numbers: | 2009X41 |
| Study First Received: | July 19, 2011 |
| Last Updated: | August 2, 2011 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Guangdong General Hospital:
|
contrast-induced nephropathy contrast medium creatinine clearance percutaneous coronary intervention |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013