CONVIN: Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention

• Sponsor: Guangdong Provincial People's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01399203
• Collaborator: Hainan People's Hospital (Other), Guangdong Medical College (Other)
• Enrollment: 2,000
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 83.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2011
• Anticipated Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
percutaneous coronary intervention The investigators reviewed all consecutive patients who were undergoing percutaneous coronary intervention

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ning Tan	Guangzhou	Guangdong	China	510100

Sponsors and Collaborators

• Guangdong Provincial People's Hospital
• Hainan People's Hospital
• Guangdong Medical College

Investigators

• Study Director: Yong Liu, MD, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01399203
• Other Study ID Numbers: 2009X41
• First Posted: Jul 21, 2011
• Last Update Posted: Aug 3, 2011
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: contrast-induced nephropathy; contrast medium; creatinine clearance; percutaneous coronary intervention
• Additional relevant MeSH terms: Kidney Diseases

Study Results

No Results Posted as of Aug 3, 2011