Clinical trial NCT02643706: Relationship Between ALDH2 and CIN
Official title: Relationship Between the Gene Polymorphism of Aldehyde Dehydrogenase 2 and Contrast Induced Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiographic Contrast Agent Nephropathy
Keywords: Aldehyde dehydrogenase 2
contrast induced nephropathy
Gene polymorphism
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective coronary intervention or coronary angiography in Qilu hospital from December 2015 to December 2016

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with different ALDH2 genotype
timeFrame: 1-30 days after samples collected
measure: Change from baseline renal function after the operation
timeFrame: at admission and 24-72hours after coronary angiography or coronary intervention
Secondary outcomes:
measure: Aldehyde dehydrogenase 2 activity
timeFrame: 1-30 days after samples collected
measure: Activated oxygen protein products, 4-HNE and hs-CRP
timeFrame: 1-30 days after samples collected
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Feng Xu
role: STUDY_DIRECTOR
References: