Folic Acid for Prevention of Contrast Induced Nephropathy (FAPCIN)

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

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.

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.

Oral folic acid (5 mg, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

Oral placebo (1 tablet, tid) were given at least two days before CTA/angiography/angioplasty and continued for two days after.

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

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

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.

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.

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.

Peng L, Shui X, Tan F, Li Z, Ling Y, Wu B, Chen L, Li S, Peng H. Folic Acid Attenuates Contrast-Induced Nephropathy in Patients With Hyperhomocysteinemia Undergoing Coronary Catheterization: A Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 1;8:707328. doi: 10.3389/fcvm.2021.707328. eCollection 2021.