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

NCT02560116 | Withdrawn DMC

• 1 other identifier: 14-283
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary

Keywords

Pulmonary artery systolic pressure; Optison

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After obtaining informed written consent, investigators will enroll all consecutive patients (age ≥ 18 years old) undergoing right heart catheterization in the catheterization laboratory for various clinical indications as part of routine medical care. This will be a prospective and multicenter study. The participating institutions are: North Shore University Hospital (Manhasset, NY), Long Island Jewish Medical Center (New Hyde Park, NY), and Mt Sinai Medical Center (NY, NY).

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• GE Healthcare: collaborator

Study Sites (1)

North Shore - LIJ Health System

Manhasset, New York, 11030, United States

Location

Related Publications (5)

• 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.

  PMID: 6478568 BACKGROUND

• 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.

  PMID: 11755297 BACKGROUND

• 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.

  PMID: 8662031 BACKGROUND

• 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.

  PMID: 8024373 BACKGROUND

• 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.

  PMID: 20620859 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: September 25, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

US (1)