Biochemical and Reno-protective Effects of Remote Ischemic Pre-conditioning on Contrast-induced Acute Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Number of Patients With Acute Kidney Injury
研究概览
简要总结
This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention.
详细描述
The BRICK study is a prospective, double-blind, sham-controlled, randomized clinical trial in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention who are at high risk for acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of coronary angiography and/or percutaneous coronary intervention.
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)
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
- •Patient with non-ST elevation myocardial infarction or unstable angina
- •Referral for cardiac catheterization and percutaneous coronary intervention
- •Contrast-induced acute kidney injury risk score of ≥11
排除标准
- •Inability to give informed consent
- •unstable blood pressure (systolic blood pressure > 200 or <90 mmHg)
- •History of allergy to contrast media
- •Peripheral vascular disease of upper limb
- •Renal disease requiring dialysis
- •Placement of arteriovenous fistula and arteriovenous graft
结局指标
主要结局
Number of Patients With Acute Kidney Injury
时间窗: 24-48 hours post coronary angiography
acute kidney injury is defined as a relative increase in serum creatinine of ≥ 0.3mg/dl within 48 hours post catheterization compared with baseline creatinine before coronary angiography.
次要结局
- The Product of Urinary (Tissue Inhibitor of Metalloproteinases 2) X (Insulin-like Growth Factor-binding Protein 7)(0-48hrs)
- Number of Patients With Major Adverse Cardiovascular and Cerebrovascular Event(6 months post coronary angiography)
- Number of Patients With Major Adverse Kidney Event(6 months post coronary angiography.)
- Cyclic Guanylate Monophosphate (cGMP) Level(0-48 Hrs)
研究者
Oladipupo Olafiranye, MD, MS
Associate Professor of Medicine
University of Pittsburgh