Urine Adiponectin Concentration in Prediction of Contrast Induced Nephropathy
| Tracking Information | |||||
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| First Received Date ICMJE | June 10, 2011 | ||||
| Last Updated Date | November 21, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
increase in SCr 0.5 mg/dL(44.2 mol/L) from baseline [ Time Frame: 3 days ] [ Designated as safety issue: No ] samples will be collected at 24, 48 and 72 hours after PCI |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01372891 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
a 25% increase in SCr from baseline [ Time Frame: 3 days ] [ Designated as safety issue: No ] samples will be collected at 24, 48 and 72 hours after PCI. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Urine Adiponectin Concentration in Prediction of Contrast Induced Nephropathy | ||||
| Official Title ICMJE | Urine Total Adiponectin and Its Isoforms Concentration in Prediction of Percutaneous Coronary Interventions Contrast Induced Nephropathy | ||||
| Brief Summary | The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of contrast induced nephropathy (CIN) in the patients undergoing PCI. |
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| Detailed Description | Contrast induced nephropathy (CIN) is a severe complication after percutaneous coronary intervention (PCI). CIN is responsible for approximately genic renal insufficiency and is the third cause of hospital-acquired renal failure and the injury of endothelial of renal tubule is responsible for the CIN. However markers reliably identifying CIN in the patients undergoing PCI are rare. Adiponectin is a 30-kDa adipocyte-derived vasoactive peptide closely linked to components of the metabolic syndrome. Recent study demonstrates that the quantification of urinary adiponectin excretion appears to be an independent indicator of vascular damage potentially identifying an increased risk for vascular events. Therefore, the investigators presume that the adiponectin excretion may predict the incidence of the CIN. The present study is to determine the ability of urinary total adiponectin and its isoforms excretion in the prediction of CIN in the patients undergoing PCI. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: serum,urine |
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| Sampling Method | Probability Sample | ||||
| Study Population | This study enrolls a group of patients> 18 who have ST elevation myocardial infarction (STEMI) undergoing primary PCI. |
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| Condition ICMJE | Myocardial Ischemia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Patients underging PCI | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01372891 | ||||
| Other Study ID Numbers ICMJE | xjyy110502 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Xijing Hospital | ||||
| Study Sponsor ICMJE | Xijing Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Xijing Hospital | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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