Effect of Inorganic Nitrate on Contrast-induced Nephropathy in Patients Undergoing Coronary Angiography/Percutaneous Coronary Intervention for Acute Coronary Syndrome (ACS): A Randomised Single-centre, Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Contrast Induced Nephropathy
研究概览
简要总结
Contrast-induced nephropathy (CIN), an acute kidney injury resulting from the administration of intravascular iodinated contrast media, is an important cause of morbidity/mortality 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.
详细描述
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 (e.g. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
IMP and placebo will be identical
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing coronary angiography+/-Percutaneous Coronary Intervention (PCI) for NSTE-ACS
- •Requirement for CIN prophylaxis as per Barts Heart Centre Criteria for CIN prophylaxis:
- •eGFR<60ml/min OR 2 of the following: diabetes, liver failure (cirrhosis), age > 70yr, exposure to contrast in last 7 days, heart failure (or LVEF<40%), concomitant renally active drugs (ACEi, ARB, NSAIDs, aminoglycosides, diuretics)
- •Patients able and willing to give their written informed consent.
排除标准
- •ST segment myocardial infarction undergoing Primary PCI.
- •Patients with eGFR<30ml/min or on renal replacement therapy
- •Subjects presenting with cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation
- •Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
- •Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of study medication.
- •Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).
- •Severe acute infection
- •Breast-feeding mothers.
- •Any Inclusion Criteria not met
研究组 & 干预措施
Potassium Nitrate
Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days
干预措施: Potassium Nitrate (Drug)
Potassium Chloride
Potassium Chloride
干预措施: Potassium Chloride (Drug)
结局指标
主要结局
Contrast Induced Nephropathy
时间窗: 48-72 hours
Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria
次要结局
- Measurement of Circulating Nitrite and Nitrate levels(Baseline, and at 6 hours, 48 hours and 3 months following treatment.)
- To determine if dietary inorganic nitrate ingestion decreases sub-clinical renal injury as measured by serum biomarkers(4-6 hours)
- To determine if dietary inorganic nitrate decreases rates of post-procedural Myocardial Infarction(6-12 hrs)
- Major Adverse Cardiac Events(3 and 12 months follow-up)
- Cost effectiveness of dietary inorganic Nitrate(1 year)
- Demonstration of a persistent benefit of dietary inorganic nitrate against long-term renal impairment(3 months)
- To determine if dietary inorganic nitrate ingestion decreases sub-clinical renal injury as measured by urinary renal biomarkers(4-6 hours)