Correlation of Auscultatory Severity of Aortic Stenosis With Trans Thoracic Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
研究概览
简要总结
According to the 2006 ACC/AHA practice guidelines for valvular heart disease, patients with asymptomatic aortic stenosis(AS) should have screening transthoracic echocardiograms (TTE) performed annually for severe disease, every 1-2 years for moderate disease and every 3-5 years for mild disease. This results in a multitude of screening studies in the investigators patient population. 3M has developed a new stethoscope and phonocardiography software capable of identifying the peak intensity of the AS murmur and tracking it as it moves towards the second heart sound potentially indicating increasing severity of disease. Currently there exists no data to demonstrate that the aortic stenosis acceleration index (ASAI) correlates to disease severity or progression of disease. The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. In this study the investigators propose to correlate the ASAI to standard TTE measurements of aortic stenosis severity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male and female subjects 18 years of age and older.
- •Subjects must have asymptomatic Aortic Stenosis documented by prior echocardiographic examination.
- •Subjects must be able to sit for auscultation examination.
- •Subject must be able to complete a TTE .
- •Subjects must voluntarily agree to participate in the study and sign the informed consent and healthcare information authorization forms.
排除标准
- •Subjects with significant additional valvular heart disease.
- •Subjects with unrecordable heart sounds.
- •Subjects with known or who may have been previously diagnosed with congenital heart disease.
- •Subjects with atrial fibrillation.
- •Subjects with history of cardiac surgery.
- •Subjects who have conditions which the researcher feels may limit the recordability of the heart sounds or the accuracy of the echocardiogram.
结局指标
主要结局
Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity
时间窗: There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.
The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of \>30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.
次要结局
未报告次要终点