Benefits of Chronic Total Coronary Occlusion Percutaneous Intervention in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Left ventricular ejection fraction (%)
研究概览
简要总结
The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.
详细描述
Observational studies have shown that chronic total coronary occlusion percutaneous intervention (CTO-PCI) improves angina, left ventricular ejection fraction (LVEF), and survival. None of these studies aimed to assess the benefits in populations with heart failure with reduced ejection fraction (HFrEF). The investigators studied the effect of CTO-PCI on left ventricular function and clinical parameters in patients with HFrEF.
Using cardiac magnetic resonance (CMR), the investigators studied 29 patients with HFrEF and evidence of viability and/or ischemia in the territory supplied by an occluded vessel who were successfully treated with CTO-PCI. Non-CTO PCI was also performed in patients with multi-vessel disease, . Imaging parameters, clinical status, and brain natriuretic peptide (BNP) levels were evaluated before and six months after CTO-PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one chronic total coronary occlusion
- •LVEF ≤40% by CMR
- •Evidence of myocardial viability and/or ischemia in at least two contiguous segments subtended by the occluded vessel.
排除标准
- •Women of childbearing age or pregnant
- •Claustrophobia
- •Admission to hospital within the previous 90 days due to decompensated heart failure, myocardial infarction or unstable angina.
- •Severe valvulopathy
- •Pacemaker or implantable cardioverter defibrillator
- •Indication for coronary artery bypass surgery
- •Heart transplantation waiting list
- •Follow-up not feasible
- •Life expectancy shorter than 12 months.
- •Iodine contrast or gadolinium allergy
- •Aspirin or clopidogrel allergy
- •NYHA IV class
- •Liver cirrosis
- •Noncompliance with medical treatment
- •Chronic kidney disease with serum creatinine levels ≥ 2.5 mg/dl or glomerular filtration rate ≤30 ml/min/1.73m2
- •Evidence of active bleeding
- •High risk of bleeding
- •CTO distal vessel not visible through collateral circulation
- •CTO distal vessel diameter <2mm
- •Absence of acceptable vascular access
结局指标
主要结局
Left ventricular ejection fraction (%)
时间窗: 6 months
Evaluate changes in left ventricular function by cardiac magnetic resonance imaging 6 months after CTO PCI
次要结局
- NYHA functional class (I-V)(6 months)
- Myocardial ischemia(6 months)
- Brain Natriuretic Peptide (pg/ml)(6 months)
- Incidence of in-hospital CTO PCI major adverse events(6 months)
研究者
Montserrat Cardona
Consultant
Hospital Clinic of Barcelona