Relationship Between ALDH2 and CIN

NCT02643706 | Unknown

• 1 other identifier: Qiluexcellentyouth
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

Aldehyde dehydrogenase 2; contrast induced nephropathy; Gene polymorphism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

5 ml vein blood samples were collected from peripheral vein before coronary angiography or percutaneous coronary intervention.The blood is used to detecte the renal function , the genotype of aldehyde dehydrogenase 2 and aldehyde dehydrogenase activity. Another 5 ml vein blood samples were collected from peripheral vein to detecte the renal function 24-72 hours after the surgery. The samples would be centrifuged and saved in a -80℃ ultra-low temperature refrigerator.

Study Officials

• Feng Xu

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Feng Xu

CONTACT

18560083066; Xufengsdu@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

CN (1)