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

NCT ID: NCT02560116

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Pulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GE Healthcare

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Shore - LIJ Health System

Manhasset, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1161/01.cir.70.4.657.

Reference Type BACKGROUND
PMID: 6478568 (View on PubMed)

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. doi: 10.1016/s0735-1097(01)01698-9.

Reference Type BACKGROUND
PMID: 11755297 (View on PubMed)

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. doi: 10.1007/BF02505208.

Reference Type BACKGROUND
PMID: 8662031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8024373 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 20620859 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

14-283

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.