Evaluation of Cardiopulmonary Diseases by Ultrasound

Description

Historically, ultrasound imaging of the lung parenchyma has been challenging because of the high total ultrasound energy attenuation and scattering by the air in the lungs. However, recent technological advancements have allowed for rapid assessment of various pulmonary diseases via the use of lung ultrasound. Furthermore, it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal-processing package. The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general. In a pilot clinical validation study of patients with acute decompensated heart failure (ADHF) patients, LDS signals unique to ADHF patients were identified, that superpose on the normal Lung Doppler Signals (unpublished data). These are high velocity "disorganized" variable signals that are not synchronous with the cardiac cycle but rather sometimes with respiration.

Study Start Date

September 2014

Estimated Completion Date

April 2017

Interventions

  • Device: Recording Doppler ultrasound signals noninvasively

Specialties

  • Cardiology: Heart Failure
  • Pulmonology: CV/Thromboembolic
  • Radiology: Ultrasound

MeSH Terms

  • Heart Failure
  • Pulmonary Heart Disease

Study ID

Echosense Ltd. -- DOP19

Status

Unknown

Trial ID

NCT02248831

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

600

Sponsor

Echosense Ltd.

Inclusion Criteria

  • Phase 1(ED): Inclusion criteria: Age > 18 years Acute onset dyspnea
  • Phase 2 (Inpatient): Age > 18 years Acute onset dyspnea: defined as SOB at rest or with minimal activity, with onset within the past 48 hours PLUS The following criteria are required to be classified as heart failure (event has to meet all of the following criteria): a) The patient exhibits documented new or worsening symptoms due to heart failure on presentation, including at least one of the following: i) Dyspnea (dyspnea with exertion, dyspnea at rest, orthopnea) ii) Decreased exercise tolerance b) The patient has objective evidence of new or worsening heart failure, consisting of at least two physical exam findings (or one physical exam finding and one diagnostic criterion) including: i) Physical exam findings considered to be due to heart failure, including new or worsened: (1) Peripheral edema (2) Increasing abdominal distention or ascites (in the absence of primary hepatic disease) (3) Increased jugular venous pressure and/or hepatojugular reflux (4) Rapid weight gain thought to be related to fluid overload ii) Diagnostic findings considered to be due to heart failure, including new or worsened: 1. Increased B-type natriuretic peptide/ NT-proBNP concentrations consistent with decompensation of heart failure Note: In patients with chronically elevated natriuretic peptides, a significant increase should be noted above baseline. 2. Radiological evidence of pulmonary congestion

Exclusion Criteria

  • Phase 1 (ED): Pregnant women Inability to consent
  • Phase 2 (Inpatient): Pregnant women Pneumonia
  • currently, or within the past 30 days Non-cardiogenic pulmonary edema (e.g. ARDS) Interstitial lung disease Inability to consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Emergency Medicine department and Inpatients floorsMGH - Boston, Massachusetts 2.8 miles Maulik Majmudar Dr 617-726-3020 mmajmudar@partners.org

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