NCT02444013

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

2 years

First QC Date

April 7, 2015

Last Update Submit

May 11, 2015

Conditions

Kidney DiseasesUrologic Diseases

Keywords

Contrast induced nephropathy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (2)

Folic acid

ACTIVE COMPARATOR

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

Drug: Folic acid

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Folic acidDRUG
Also known as: Folic uric acid
Folic acid
PlaceboDRUG
Placebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients undergoing coronary CTA/angiography/angioplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 21791335BACKGROUND

  • 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.

    PMID: 24830422BACKGROUND

  • 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.

    PMID: 25687162BACKGROUND

  • 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.

    PMID: 34660712DERIVED

MeSH Terms

Conditions

Kidney DiseasesUrologic Diseases

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jinlai Liu, M.D.

    Organizational Affiliation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhua Li, M.D.

CONTACT

86-020-85252168IMUAWUB@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2015

First Posted

May 14, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

CN(1)