Detection and Outcomes of Myocardial Microvascular Disease in Patients With End Stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Major cardiovascular events
研究概览
简要总结
Cardiovascular diseases are the leading cause of mortality in patients with end stage renal disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the incidence of significant coronary stenosis (>70%) is low. The goal of this observational study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular disease in patients with end stage renal disease scheduled or not for kidney transplantation. These patients routinely undergo non invasive detection of myocardial ischemia. Patient included in the study will be followed up for 2 years for major cardiovascular events. Patients with detected myocardial ischemia during non invasive testing are being explored by coronary angiography. During coronary angiography additional detection of myocardial microvascular disease is being performed by simultaneous measurement of Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of microcirculatory resistance (IMR).
Comparison of cardiovascular outcomes between patients with and without myocardial ischemia and patients with and without myocardial microvascular disease will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients age > 18 years with end stage renal disease under dialysis and/or scheduled for kidney or kidney + pancreatic transplantation
- •Having a non invasive detection of myocardial ischemia and agreeing to participate (signed informed consent document)
排除标准
- •Past medical history of
- •Acute coronary syndrome
- •Hypertrophic cardiomyopathy
- •severe aortic and/or mitral valvular disease (grade ≥ 3)
- •Known contraindications to adenosine injection: AV block grade ≥ 2 and/or sinoatrial block unless prior implantation of a pace maker, asthma, allergic reaction to adenosine.
结局指标
主要结局
Major cardiovascular events
时间窗: Inclusion: 1 year - Follow up: 2 years
Major cardiovascular events * Death (all cause) * Acute coronary syndromes (STEMI, NSTEMI, UA) * New onset of stable angina * New onset of congestive heart failure or progression of previously known congestive heart failure (need for therapeutic intensification and/or hospital admission) * Cardiogenic shock * Stroke * Severe cardiac arrhythmia (FV, VT) * New onset of atrial fibrillation
次要结局
- Incidence of myocardial microvascular disease detected by FFR + CFR in ESRD patients with myocardial ischemia on non invasive tests.(Inclusion: 1 year)