Relationship Between ALDH2 and CIN

• Conditions: Radiographic Contrast Agent Nephropathy

• Registration Number: NCT02643706
• Lead Sponsor: Qilu Hospital of Shandong University

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 Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-19
• Study First Submitted QC: 2015-12-28
• Last Update Submitted: 2015-12-28
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with different ALDH2 genotype	1-30 days after samples collected
Change from baseline renal function after the operation	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.

Secondary Outcome Measures

Name	Time	Method
Aldehyde dehydrogenase 2 activity	1-30 days after samples collected
Activated oxygen protein products, 4-HNE and hs-CRP	1-30 days after samples collected	Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China