A Single-Center, Blinded, Randomized Control Trial Evaluating Different Approaches to Evaluation of Right Ventricular Size and Function Using the Upper Valley Right Ventricle Algorithm and Novel Imaging Modalities
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Echocardiographic measurement - Right ventricular size
研究概览
简要总结
The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient population.
详细描述
This is a single-center, blinded, randomized control trial of patients 18-years or older that are undergoing CMR as a standard of care at Dartmouth-Hitchcock Medical Center in Lebanon, NH. After informed consent is obtained, subjects undergo a study-specific external, non-invasive echocardiogram utilizing a special RV focused protocol on the same day of their CMR as close to their scheduled CMR as possible to minimize wait time for consented patients. The echocardiogram takes approximately an additional 30 minutes of the subject's time.
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three different methodologies (standard method, Phillips Novel technology and the newly developed UVRV algorithm). The methodologies will be compared with each other to determine sensitivity, specificity and accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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 age is over 18 years
- •Patient is undergoing Cardiac MRI with sequences that permit biventricular volumetric analysis
- •Patient is capable of giving informed consent
- •The cardiac MRI images are of diagnostic quality to provide accurate RV and LV volumes
排除标准
- •Patient unable to under echocardiogram
结局指标
主要结局
Echocardiographic measurement - Right ventricular size
时间窗: Echocardiographic measurements are taken on the same day as the scheduled CMR, as close to the scheduled CMR as possible, approximately 1 hour
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Specific evaluating MRI derived right ventricular volumes versus various echo approaches to grading right ventricular size.
Echocardiographic measurement - Right ventricular dysfunction severity
时间窗: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies. Severity reported as mild, moderate or severe)
Echocardiographic measurement - Right ventricular function
时间窗: Echocardiographic measurements are taken on the same day as the scheduled CMR as possible, as close to the scheduled CMR, approximately 1 hour
De-identified echocardiogram images from each subject will be evaluated by experienced echocardiographers using three (3) different methodologies.
次要结局
未报告次要终点
研究者
Eric S. Rothstein
Staff Physician, Heart and Vascular Center
Dartmouth-Hitchcock Medical Center