The Role of Echocardiographic Contrast (Optison) in Enhancing Tricuspid Regurgitation Spectral Doppler Signals

Hypertension, Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02560116
• Other study ID #: 14-283
• Status: Withdrawn
• Phase: N/A
• First received: June 24, 2015
• Last updated: January 20, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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);

Exclusion Criteria:

• 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
United States	North Shore - LIJ Health System	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (5)

Dubourg O, Delorme G, Jondeau G, Chikli F, Clavier H, Valtier B, Terdjman M, Beauchet A, Bourdarias JP. [Simultaneous measurement of systolic pulmonary artery pressure by catheterization and contrast enhancement doppler echocardiography]. Arch Mal Coeur Vaiss. 1993 Dec;86(12):1721-7. French. — View Citation

Ishii M, Kato H, Inoue O, Takagi J, Akagi T, Miyake T, Sugimura T, Maeno Y, Hashino K, Kawano T. Noninvasive evaluation of systolic pressures of pulmonary artery and right ventricle using contrast-enhanced doppler echocardiography: comparative study using sonicated albumin or glucose solution. Pediatr Cardiol. 1996 May-Jun;17(3):175-80. — View Citation

Jeon DS, Luo H, Iwami T, Miyamoto T, Brasch AV, Mirocha J, Naqvi TZ, Siegel RJ. The usefulness of a 10% air-10% blood-80% saline mixture for contrast echocardiography: Doppler measurement of pulmonary artery systolic pressure. J Am Coll Cardiol. 2002 Jan 2;39(1):124-9. — View Citation

Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. — View Citation

Yock PG, Popp RL. Noninvasive estimation of right ventricular systolic pressure by Doppler ultrasound in patients with tricuspid regurgitation. Circulation. 1984 Oct;70(4):657-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Continuous wave PASP Doppler Envelope measurements in patients receiving Optison versus conventional non-perflutren based agents (10% air-90% saline mixture).	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.	up to 6 months	No
Secondary	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	No
Secondary	Number of patients with adverse events as a measure of safety		up to 6 months	No