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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01372891
Other study ID # xjyy110502
Secondary ID
Status Recruiting
Phase N/A
First received June 10, 2011
Last updated November 21, 2011
Start date April 2010
Est. completion date December 2014

Study information

Verified date November 2011
Source Xijing Hospital
Contact Ling Tao, M.D Ph.D
Phone +86-15002955798
Email lingtao2006@gmail.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2014
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- All patients > 18 of age who are undergoing elective PCI and are able to give informed consent are eligible for study.

Exclusion Criteria:

- The end-stage renal failure

- The patients who are relieving dialysis

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary increase in SCr 0.5 mg/dL(44.2 mol/L) from baseline samples will be collected at 24, 48 and 72 hours after PCI 3 days No
Secondary a 25% increase in SCr from baseline samples will be collected at 24, 48 and 72 hours after PCI. 3 days No
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