Clinical Trial: Evaluation of Cardiopulmonary Diseases by Ultrasound
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Non-invasive Evaluation of Cardiopulmonary Diseases Using Transthoracic Parametric Doppler Based Assessment of Lung Doppler Signals
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 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patients, LDS signals unique to ADHF patients were identified, that superpose on the normal Lung Doppler Signals (unpublished data).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.
Detailed Summary:
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 major objectives and is thus, divided into two phases, which are on a continuum.
Phase 1: The objective is to further evaluate LDS among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to distinguish cardiac from pulmonary causes of dyspnea.
Phase 2: In addition, for those patients admitted to the hospital with a clinical diagnosis of ADHF, we would like to further characterize changes in daily lung Doppler signal as a surrogate biomarker of intravascular volume status, as assessed by clinical assessment.
Study Design and Methods:
1. Overall study design
Phase 1:
Prospective cohort study of patients presenting to the Massachusetts General Hospital emergency department with acute dyspnea. . In addition, at MGH, pts admitted to the cardiac floors (Ellison 9, 10, 11) and general medicine floors (White 9, 10, 11) with an admitting diagnosis of heart failure, who presented with acute dyspnea, will be approached for enrollment within 24 hours of hospital admission. All patients with acute dyspnea will undergo routine clinical assessment, laboratory testing, and diagnostic imaging. In addition, all patients will also undergo transthoracic parametric Doppler ultrasound based assessment of LDS. Patients will be treated as usual, under the direction of the attending physician. Two independent cardiologists
Sponsor: Echosense Ltd.
Current Primary Outcome: Number of patients identified with COPD (or CHF) in comparison to physician diagnosis [ Time Frame: 1y ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Identify changes in lung doppler signals according to the clinical status over few days in comparison to the physician diagnosis [ Time Frame: 1y ]
Original Secondary Outcome: Same as current
Information By: Echosense Ltd.
Dates:
Date Received: September 18, 2014
Date Started: September 2014
Date Completion: December 2017
Last Updated: March 19, 2017
Last Verified: November 2016
