Clinical trial NCT02444013: Folic Acid for Prevention of Contrast Induced Nephropathy
Official title: Periprocedural Administration of Folic Acid for Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary CTA/Angiography/Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Diseases
Urologic Diseases
Keywords: Contrast induced nephropathy
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-05-14
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of contrast-induced nephropathy
timeFrame: Within 48 hours after contrast exposure
Secondary outcomes:
measure: Major in-hospital clinical events, including death and need for dialysis or hemofiltration
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Organizational Affiliation
name: Jinlai Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.