Randomized Controlled Trial on the Efficacy and Safety of a Beet-Derived Inorganic Nitrate-Based Food Product for the Prevention of Contrast-Induced Nephropathy in High-Risk Patients Undergoing Percutaneous Coronary Intervention (BEET-CIN Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Incidence of Contrast-Induced Nephropathy (CIN)
研究概览
简要总结
Contrast-induced nephropathy (CIN) is a common complication in high-risk patients undergoing percutaneous coronary intervention (PCI) due to exposure to iodinated contrast agents. CIN is associated with increased morbidity, prolonged hospital stays, and higher healthcare costs. Current preventive strategies include adequate hydration and minimizing contrast volume; however, there is no universally effective pharmacological intervention.
Recent studies suggest that inorganic nitrates can enhance renal perfusion, reduce oxidative stress, and improve endothelial function, potentially lowering the risk of CIN. This study aims to evaluate the efficacy and safety of a beet-derived inorganic nitrate-based food product for the prevention of CIN in high-risk patients undergoing PCI.
This is a randomized, controlled, open-label clinical trial comparing two groups:
- Intervention Group: Patients receiving the beet-derived inorganic nitrate-based food product for 5 days (starting 24 hours before PCI).
- Control Group: Patients receiving standard medical care without additional nitrate supplementation.
We hypothesize that the nitrate-based food product will significantly reduce the incidence of CIN compared to standard care. Additionally, we expect:
- A lower increase in kidney injury biomarkers (NGAL, cystatin C) in the intervention group.
- A slower decline or even improvement in eGFR at follow-up.
- A potential reduction in MACE due to the vasoprotective effects of nitrates.
- Improved quality of life scores (EQ-5D) in the intervention group. If successful, this study will provide new evidence supporting the use of dietary nitrates for renal protection and may contribute to the development of novel, cost-effective prevention strategies for CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Planned PCI.
- •High risk of CIN with:
- •eGFR according to the CKD-EPI formula <60 ml/min/1.73 m2 or
- •At least two of the following criteria: liver damage (cirrhosis), diabetes mellitus, age >70 years, administration of contrast in the last 7 days, CHF (LVEF >40%), intake of drugs affecting renal function (ACE inhibitors, ARBs, NSAIDs, aminoglycosides, diuretics).
- •Signing informed consent.
排除标准
- •Allergy to nitrates.
- •Acute coronary syndrome.
- •Acute condition accompanied by systolic blood pressure <90 mmHg for more th an 30 minutes or requiring the use of drugs with a positive inotropic effect.
- •Life-threatening conditions requiring emergency medical care.
- •Participation in other clinical trials.
- •Pregnancy, lactation.
- •Use of nitrates in the last 30 days.
- •Abuse of alcohol, illegal drugs, mnestic-intellectual decline, as well as other reasons and circumstances indicating expected low adherence to treatment.
- •Refusal to follow the plan of visits and examinations provided for by the protocol of this clinical trial.
- •Refusal to sign informed consent.
- •Infectious diseases.
结局指标
主要结局
Incidence of Contrast-Induced Nephropathy (CIN)
时间窗: Baseline, 48 hours post-PCI
Contrast-induced nephropathy (CIN) will be defined based on KDIGO criteria as: * An increase in serum creatinine of ≥0.3 mg/dL (26.52 μmol/L) within 48 hours post-PCI, OR * An increase in serum creatinine of ≥1.5 times from baseline within 7 days post-PCI. * A urine output \< 0.5 mL/kg/hour for six hours. The incidence of CIN will be compared between the intervention (nitrate supplementation) and control groups.
次要结局
- Changes in Renal Function Biomarkers (NGAL, Cystatin C, eGFR)(Baseline, 4-6 hours, 24 hours, 48 hours, and 3 months post-PCI)
- Incidence of Major Adverse Cardiovascular Events (MACE)(3 months and 12 months post-PCI)
- Quality of Life Assessment (EQ-5D Score)(Baseline and 12 months post-PCI)