Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03627130
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2018-01-17
Brief Title:
The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
Effect of Inorganic Nitrate on Contrast-induced Nephropathy in Patients Undergoing Coronary AngiographyPercutaneous Coronary Intervention for Acute Coronary Syndrome ACS A Randomised Single-centre Double-blind Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NITRATE-CIN
Brief Summary:
Contrast-induced nephropathy CIN an acute kidney injury resulting from the administration of intravascular iodinated contrast media is an important cause of morbiditymortality following coronary angiographic procedures in high-risk patients Despite preventative measures intended to mitigate the risk of CIN there remains a need for an effective intervention Dietary inorganic nitrate therapy which through its chemical reduction in the body delivers nitric oxide has shown promise in attenuating CIN but its effectiveness in preserving long-term renal function is unknown
Detailed Description:
The NITRATE-CIN trial is a single-centre randomised double-blinded placebo-controlled trial which plans to recruit over a period of 2 years 640 patients presenting with acute coronary syndromes ACS who are at risk of CIN
Patients will be randomised to either dietary inorganic nitrate therapy or placebo
The primary endpoint will be the development of CIN KDIGO criteria A key secondary endpoint will be whether nitrate therapy impacts upon persistent renal impairment over a 3-month follow-up period Additional secondary endpoints include the measurement of serum renal biomarkers eg neutrophil gelatinase-associated lipocalin and urinary albumin at 6 48 h and 3 months following administration of contrast
Findings from NITRATE-CIN will potentially demonstrate that nitrate attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures
Patients will be randomised to either dietary inorganic nitrate therapy or placebo
The primary endpoint will be the development of CIN KDIGO criteria A key secondary endpoint will be whether nitrate therapy impacts upon persistent renal impairment over a 3-month follow-up period Additional secondary endpoints include the measurement of serum renal biomarkers eg neutrophil gelatinase-associated lipocalin and urinary albumin at 6 48 h and 3 months following administration of contrast
Findings from NITRATE-CIN will potentially demonstrate that nitrate attenuates contrast-induced acute and chronic kidney injury and influence future clinical practice guidelines in at-risk patients undergoing coronary angiographic procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None