The Role of Echocardiographic Contrast (Optison) in Enhancing Tricuspid Regurgitation Spectral Doppler Signals
- Conditions
- Hypertension, Pulmonary
- Registration Number
- NCT02560116
- Lead Sponsor
- Northwell Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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);
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 up to 6 months
- Secondary Outcome Measures
Name Time Method 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 Compare the diagnostic role of Optison versus conventional non-perflutren based agents (10% air-90% saline mixture) in enhancing inadequate TR continuous wave spectral Doppler envelopes. This will be done by measuring the values obtained from echocardiographic and invasive hemodynamics with respect to PASP.
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
Trial Locations
- Locations (1)
North Shore - LIJ Health System
🇺🇸Manhasset, New York, United States