Status:
COMPLETED
Evaluation of Cardiopulmonary Diseases by Ultrasound
Lead Sponsor:
Echosense Ltd.
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Dyspnea
Acute Decompensated Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 technologic...
Detailed Description
Study Purpose and Rationale The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The study has two majo...
Eligibility Criteria
Inclusion
- 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 14 days 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:
- 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.
- Radiological evidence of pulmonary congestion
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT02248831
Start Date
September 1 2014
End Date
December 1 2018
Last Update
February 8 2019
Active Locations (1)
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1
Emergency Medicine department and Inpatients floors,MGH
Boston, Massachusetts, United States, 02114