Folic Acid for Prevention of Contrast Induced Nephropathy

Kidney Diseases Clinical Trial

— FAPCIN  

Official title:

Periprocedural Administration of Folic Acid for Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary CTA/Angiography/Angioplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444013
• Other study ID #: SYSU-2015
• Status: Recruiting
• Phase: Phase 4
• First received: April 7, 2015
• Last updated: May 11, 2015
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2015
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Suhua Li, M.D.
• Phone: 86-020-85252168
• Email: IMUAWUB[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether periprocedural administration of folic acid is effective in the prevention of contrast induced nephropathy in patients undergoing coronary CTA/angiography/angioplasty.

Description:

Hyperhomocysteinemia is considered to be independently associated with a greater risk of contrast induced nephropathy (CIN) in previous studies. However, the relationship between homocysteine-lowering therapy and CIN remains uncertain. Folic acid is considered to be the most common agent for homocysteine-lowering therapy. Therefore, this study aims to determine whether periprocedural administration of folic acid is effective in the prevention of CIN. 400 patients undergoing coronary CTA/angiography/angioplasty are going to be initially enrolled. Of these patients,200 were randomly assigned to receive a standard dose of folic acid (5mg tid, given at least two days before the procedural and continued for two days after), 200 to receive placebo. Blood samples for estimations of serum creatinine were collected at 0, 24 and 48h of contrast agent administration. CIN is defined as an elevation of creatinine by ≥ 25% or ≥ 0.5 mg/dl from baseline within 48h. The occurrence of CIN and the major in-hospital clinical events were recorded and compared between the intervention and control groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Inpatients undergoing coronary CTA/angiography/angioplasty

Exclusion Criteria:

• exposure to nephrotoxic drugs prior to or during the study period

• end-stage renal failure requiring dialysis

• allergy to iodine-containing contrast medium

• pregnancy

• refusal to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Diseases
• Urologic Diseases

Intervention

Drug:
• Folic acid

• Placebo

Locations

Country	Name	City	State
China	Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Barbieri L, Verdoia M, Schaffer A, Niccoli G, Perrone-Filardi P, Bellomo G, Marino P, Suryapranata H, Luca GD. Elevated homocysteine and the risk of contrast-induced nephropathy: a cohort study. Angiology. 2015 Apr;66(4):333-8. doi: 10.1177/0003319714533401. Epub 2014 May 15. — View Citation

Kim SJ, Choi D, Ko YG, Kim JS, Han SH, Kim BK, Kang SW, Hong MK, Jang Y, Choi KH, Yoo TH. Relation of homocysteinemia to contrast-induced nephropathy in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2011 Oct 15;108(8):1086-91. doi: 10.1016/j.amjcard.2011.06.010. Epub 2011 Jul 24. — View Citation

Li S, Tang X, Peng L, Luo Y, Zhao Y, Chen L, Dong R, Zhu J, Chen Y, Liu J. A head-to-head comparison of homocysteine and cystatin C as pre-procedure predictors for contrast-induced nephropathy in patients undergoing coronary computed tomography angiography. Clin Chim Acta. 2015 Apr 15;444:86-91. doi: 10.1016/j.cca.2015.02.019. Epub 2015 Feb 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of contrast-induced nephropathy	Contrast-induced nephropathy is defined as an elevation of serum creatinine of more than 25% or =0.5 mg/dl (44 µmol/l) from baseline within 48 hours after contrast exposure	Within 48 hours after contrast exposure	Yes
Secondary	Major in-hospital clinical events, including death and need for dialysis or hemofiltration		participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes