Skip to main content
Clinical Trials/NCT02643706
NCT02643706
Unknown
Not Applicable

Relationship Between the Gene Polymorphism of Aldehyde Dehydrogenase 2 and Contrast Induced Nephropathy

Qilu Hospital of Shandong University1 site in 1 country500 target enrollmentStarted: December 2015Last updated:

Overview

Phase
Not Applicable
Enrollment
500
Locations
1
Primary Endpoint
Change from baseline renal function after the operation

Overview

Brief Summary

The purpose of this clinical trial is to investigate the relationship between the gene polymorphism of aldehyde dehydrogenase 2 and contrast induced nephropathy and its mechanism.

Detailed Description

Patients undergoing coronary angiography or percutaneous coronary intervention will be recruited in this study after they sign the informed consent.5ml venous blood was extracted from the peripheral vein before the operation to detect the renal function, the genotype and enzyme activity of aldehyde dehydrogenase 2 ,and the levels of oxidative stress and inflammation.Another 5ml venous blood was extracted from the peripheral vein 24-72 hours after the operation to detect the renal function and the levels of oxidative stress and inflammation.Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.The renal function index contains serum creatinine,urea nitrogen and cystatin C.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing elective coronary intervention or coronary angiography at Yu Qilu hospital.
  • All the patients or their guardians must sign the consent form before entering the trial.

Exclusion Criteria

  • Patients with acute renal failure, renal transplantation, end-stage renal disease, or dialysis treatment, GFR \< 15ml/min.
  • Use of renal toxicity drugs during the treatment, such as non steroidal anti-inflammatory drugs, etc.
  • Patients who has used contrast agent 10 days before the operation.
  • Cardiac shock, hypotension (systolic blood pressure \< 95mmHg),or hyper- tension with difficulty to control.
  • Allergy to contrast media.
  • Congestive heart failure (left ventricular ejection fraction\<40%), cardiac function NYHA grade IV.
  • Pregnancy or lactation.

Outcomes

Primary Outcomes

Change from baseline renal function after the operation

Time Frame: at admission and 24-72hours after coronary angiography or coronary intervention

The baseline of renal function will be tested at the next morning after admission .The renal function will be tested again 24-72 hours after coronary angiography or coronary intervention.The changes of renal function will be recorded.The renal function index contains serum creatinine,urea nitrogen and cystatin C.

Number of patients with different ALDH2 genotype

Time Frame: 1-30 days after samples collected

Secondary Outcomes

  • Activated oxygen protein products, 4-HNE and hs-CRP(1-30 days after samples collected)
  • Aldehyde dehydrogenase 2 activity(1-30 days after samples collected)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials