Cardiac Magnetic Resonance Imaging After Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- CRT Response
研究概览
简要总结
This study is evaluating how MRI after CRT can provide key insights regarding LV function, structure, and mechanics resulting from CRT in patients with or without LV scar and inform optimal pacing strategies. The expected accurate and reproducible response assessment with cardiac MRI has important implications for evaluating CRT outcomes in clinical trials, and the insights from the post-CRT MRI promise to improve implementation of CRT.
详细描述
We are performing a study of 40 patients with current accepted indications for CRT and no MRI contraindications. These patients will have a pre-CRT MRI and another post-CRT MRI 6 months after the CRT procedure. Echocardiography, cardiopulmonary exercise testing, symptom assessment, and laboratory testing are also performed before and after CRT. Modifications to the post-CRT MRI protocol include the use of gradient echo cine imaging rather than steady state free precession imaging, application of wideband imaging to the LGE acquisitions, and strain imaging with cine Displacement Encoding with Stimulated Echoes (DENSE) tailored for device patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 85 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 IIa indication for CRT
- •25 and 85 years old
- •Predominantly in sinus rhythm
- •GFR ≥ 40 ml/min/1.73m2* *Contrast will not be given for the 6-month follow-up scan if the GFR falls to < 40 ml/min/1.73m2.
排除标准
- •Inability to provide informed consent
- •Pregnancy
- •Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
- •Preexisting pacemaker or defibrillator prior to enrollment
- •Cerebral aneurysm clips; 6) cochlear implants
- •Other metallic implants (prior to enrollment) known to be contraindications to MRI
- •Severe claustrophobia
- •Acute kidney injury
- •Acute renal failure or chronic kidney disease with GFR < 40 cc/min
- •Liver transplant
- •Gadolinium allergy
结局指标
主要结局
CRT Response
时间窗: 1 year
CRT Response
次要结局
未报告次要终点
研究者
Kenneth Bilchick, MD
Associate Professor
University of Virginia