Relationship Between ALDH2 and CIN (REACTION)

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

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.

Study Overview

• Status: Unknown
• Conditions: Radiographic Contrast Agent Nephropathy

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Feng Xu, M.D., Ph.D.; Phone Number: 86-18560083066; Email: xufengsdu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective coronary intervention or coronary angiography in Qilu hospital from December 2015 to December 2016

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
CIN; 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; The enrolled patients without CIN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with different ALDH2 genotype		1-30 days after samples collected
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aldehyde dehydrogenase 2 activity		1-30 days after samples collected
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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Director: Feng Xu, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 19, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: contrast induced nephropathy; Aldehyde dehydrogenase 2; Gene polymorphism
• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: Qiluexcellentyouth