The Role of Echocardiographic Contrast (Optison) in Enhancing Tricuspid Regurgitation Spectral Doppler Signals to Assess Pulmonary Artery Systolic Pressures. Correlation With Invasive Measurements Obtained by Right Heart Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Noninvasively derived PASP values in patients with versus without Optison enhanced TR continuous wave (CW) spectral Doppler envelopes in patients with technically inadequate studies to PASP measurements obtained invasively and simultaneously
研究概览
简要总结
The investigators aim to correlate noninvasive pulmonary artery systolic pressure (PASP) measurements obtained with and without echocardiographic contrast (Optison) during transthoracic echocardiography (TTE) with those obtained invasively and simultaneously during right heart catheterization, as the gold standard.
详细描述
In the United States, pulmonary hypertension (PHT) is an increasingly recognized cause of morbidity and mortality.
Echocardiography, due to its widespread use, versatility, portability, noninvasive nature, and safety, is routinely used as the primary method for diagnosis and evaluation of these patients. However, in this very cohort, its accuracy is frequently compromised by poor acoustic windows. The use of echocardiographic contrast (EC) in such patients may increase diagnostic accuracy, eliminate the need for performing more invasive, time-consuming, and expensive tests, and eliminate potential diagnostic and management errors.
Pulmonary Artery Systolic Pressure (PASP) is routinely measured noninvasively with transthoracic echocardiography (TTE) by obtaining the tricuspid regurgitant velocity (TRV) with continuous wave spectral Doppler and applying the modified Bernoulli equation.
The investigators aim to use the FDA approved perflutren-based EC agent Optison to augment inadequate TR CW spectral Doppler envelopes and determine if the TRV and PASP measurements obtained with the use of Optison correlate better with the invasive measurements obtained simultaneously during right heart catheterization as opposed to those measurements obtained without the use of EC.
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
- •consecutive patients (age ≥ 18 years old) undergoing right heart catheterization catheterization laboratory for various clinical indications as part of routine medical care;
- •only patients with poor acoustic windows will be included (based on previous studies, body habitus);
排除标准
- •atrial fibrillation or other irregular rhythms (bigeminy, frequent ectopy)
- •pregnant women
- •known allergy to perflutren, blood products, albumin
- •patients who cannot receive blood products due to religious beliefs
- •evidence of intracardiac right to left shunting
结局指标
主要结局
Noninvasively derived PASP values in patients with versus without Optison enhanced TR continuous wave (CW) spectral Doppler envelopes in patients with technically inadequate studies to PASP measurements obtained invasively and simultaneously
时间窗: up to 6 months
次要结局
- Continuous wave PASP Doppler Envelope measurements in patients receiving Optison versus conventional non-perflutren based agents (10% air-90% saline mixture).(up to 6 months)
- Invasive hemodynamic values in patients who undergo perflutren based EC (Optison) administration on PASP values in patients with normal or elevated PASP.(up to 6 months)
- Number of patients with adverse events as a measure of safety(up to 6 months)