Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Left ventricular end-systolic volume (LVESV) improvement
研究概览
简要总结
This is a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.
详细描述
At baseline, patients will have CMR, CTA, echocardiography, blood testing, and cardiopulmonary exercise testing. They will also complete a heart failure questionnaire. In patients randomized to CMR guidance for the CRT procedure, LV lead placement will be guided by the MRI information related to scar, activation and anatomy. Patients will have follow-up assessments at 6 and 12 months. There will also be clinical follow-up for survival free of appropriate ICD therapies over 3 years.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic systolic HF
- •LVEF 35% or less
- •Guideline-based class I or II indication for CRT
排除标准
- •Inability to provide informed consent
- •Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
- •Cerebral aneurysm clips
- •Cochlear implants
- •Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
- •Severe claustrophobia
- •Acute kidney injury
- •Acute renal failure or chronic kidney disease with GFR < 45 cc/min/1.73m2
- •Liver transplant
- •Gadolinium allergy
- •>10% premature ventricular contraction (PVC) burden; and 13) estimated >10% atrial fibrillation (AF) burden based on available clinical data.
研究组 & 干预措施
Intervention
CMR-Guided CRT
干预措施: CMR/CTA Guidance for CRT (Diagnostic Test)
Control
Standard CRT
结局指标
主要结局
Left ventricular end-systolic volume (LVESV) improvement
时间窗: One Year
Change in LVESV with cardiac resynchronization therapy (CRT)
次要结局
未报告次要终点
研究者
Kenneth Bilchick, MD
Associate Professor of Medicine
University of Virginia