Relationship Between ALDH2 and CIN

Radiographic Contrast Agent Nephropathy Clinical Trial

— REACTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02643706
• Other study ID #: Qiluexcellentyouth
• Status: Recruiting
• Phase: N/A
• First received: December 19, 2015
• Last updated: December 28, 2015
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Qilu Hospital
• Contact: Feng Xu
• Phone: 18560083066
• Email: Xufengsdu[@]126.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Diseases
• Radiographic Contrast Agent Nephropathy

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with different ALDH2 genotype		1-30 days after samples collected	No
Primary	Change from baseline renal function after the operation	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.	at admission and 24-72hours after coronary angiography or coronary intervention	No
Secondary	Aldehyde dehydrogenase 2 activity		1-30 days after samples collected	No
Secondary	Activated oxygen protein products, 4-HNE and hs-CRP	Activated oxygen protein products , 4-HNE and hs-CRP as markers for oxidative stress and inflammation.	1-30 days after samples collected	No