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Relationship Between ALDH2 and CIN (REACTION)

S

Shandong University

Status

Unknown

Conditions

Radiographic Contrast Agent Nephropathy

Study type

Observational

Funder types

Other

Identifiers

NCT02643706
Qiluexcellentyouth

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

CIN
Description:
CIN was defined as an absolute increase in serum creatinine concentration of at least 0.5 mg/dL (44.2umol/l) or a relative rise of at least 25% from baseline on the follow-up blood sample drawn 24 to 72 hours after the operation.
Control
Description:
The enrolled patients without CIN.

Trial contacts and locations

1

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Central trial contact

Feng Xu

Data sourced from clinicaltrials.gov

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