Urine Adiponectin Concentration in Prediction of Contrast Induced Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01372891
First received: June 10, 2011
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition
Myocardial Ischemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Urine Total Adiponectin and Its Isoforms Concentration in Prediction of Percutaneous Coronary Interventions Contrast Induced Nephropathy

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

serum,urine


Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients underging PCI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study enrolls a group of patients> 18 who have ST elevation myocardial infarction (STEMI) undergoing primary PCI.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372891

Contacts
Contact: Ling Tao, M.D Ph.D +86-15002955798 lingtao2006@gmail.com

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ling Tao, M.D Ph.D    +86-15002955798    lingtao2006@gmail.com   
Principal Investigator: Ling Tao, M.D Ph.D         
Sponsors and Collaborators
Xijing Hospital
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01372891     History of Changes
Other Study ID Numbers: xjyy110502
Study First Received: June 10, 2011
Last Updated: November 21, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Contrast Induced Nephropathy
percutaneous coronary interventions

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Kidney Diseases
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014