DyspneaNCT02248831
Evaluation of Cardiopulmonary Diseases by Ultrasound
A study testing Recording Doppler ultrasound signals noninvasively in people with Dyspnea and Acute Decompensated Heart Failure, run by Echosense Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Acute Decompensated Heart Failure
- What is being tested?
- Recording Doppler ultrasound signals noninvasively
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1(ED):
- 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):
- 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:
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Emergency Medicine department and Inpatients floors,MGH
Boston, Massachusetts, 02114
About this study
Official title: Non-invasive Evaluation of Cardiopulmonary Diseases Using Transthoracic Parametric Doppler Based Assessment of Lung Doppler Signals
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.
Read the 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 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:
- 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 will perform detailed chart review on all patients to determine the etiology of acute dyspnea. They will be blinded to the results of the LDS. In the event of discrepant findings, a third cardiologist will perform a final detailed chart review to adjudicate the diagnosis.
Additionally, radiologist employed at MGH and who are independent to the study may perform blinded adjudication of the study participants' chest x-rays (CXR) obtained in the Emergency Department on the day of enrollment into the study
Phase 2:
In addition, patients diagnosed with ADHF (diagnosed based on the criteria described below), will undergo daily TPD and assessment of LDS to further characterize changes in LDS over time, until the day of discharge or up to day 7 of hospitalization, whichever comes first. In addition to the initial inpatient scans, study staff will try to acquire a final scan within 72 hours of discharge for patients diagnosed with ADHF, regardless of the day of hospitalization. This cohort of patients will also undergo daily clinical assessment of volume status, weight measurement, and BNP assessment. In the event that repeat BNP or NT-proBNP labs have not been drawn within 72 hours of discharge, study staff will coordinate with the pathology laboratory (Dr. Kent Lewandrowski) to perform the assay as a research test using excess clinical specimen from the subject's routine clinical blood draw if available. Research subjects will not be charged for the cost of the BNP or NT-Pro-BNP assay.
- Conditions
- Dyspnea, Acute Decompensated Heart Failure
- Being tested
- Recording Doppler ultrasound signals noninvasively
- Keywords
- Dyspnea, Acute decompensated heart failure, Doppler ultrasound, Lung Doppler signals
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording Doppler ultrasound signals noninvasivelyDevice
Using ultrasound noninvasively and recording Doppler signals from the right chest wall
| Study group | Role | What they receive |
|---|---|---|
| Doppler ultrasound | Experimental | Using ultrasound noninvasively and recording Doppler signals from the right chest wall Receives: Device: Recording Doppler ultrasound signals noninvasively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients identified with COPD (or CHF) in comparison to physician diagnosis
Measured: 1y
Secondary outcomes (1)
Identify changes in lung doppler signals according to the clinical status over few days in comparison to the physician diagnosis
Measured: 1y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Maulik Majmudar, Dr, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248831
- Sponsor's protocol ID
- DOP19
- Status last verified
- Nov 2016
- First submitted
- 18 Sep 2014
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Cardiopulmonary Diseases Using Transthoracic Parametric Doppler Based Assessment of Lung Doppler Signals
- ClinicalTrials.gov ID
- NCT02248831
- Acronym / sponsor ID
- DOP19
- Conditions
- Dyspnea, Acute Decompensated Heart Failure
- Keywords
- Dyspnea, Acute decompensated heart failure, Doppler ultrasound, Lung Doppler signals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- Sep 2014
- Primary completion
- May 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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:
- 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 will perform detailed chart review on all patients to determine the etiology of acute dyspnea. They will be blinded to the results of the LDS. In the event of discrepant findings, a third cardiologist will perform a final detailed chart review to adjudicate the diagnosis.
Additionally, radiologist employed at MGH and who are independent to the study may perform blinded adjudication of the study participants' chest x-rays (CXR) obtained in the Emergency Department on the day of enrollment into the study
Phase 2:
In addition, patients diagnosed with ADHF (diagnosed based on the criteria described below), will undergo daily TPD and assessment of LDS to further characterize changes in LDS over time, until the day of discharge or up to day 7 of hospitalization, whichever comes first. In addition to the initial inpatient scans, study staff will try to acquire a final scan within 72 hours of discharge for patients diagnosed with ADHF, regardless of the day of hospitalization. This cohort of patients will also undergo daily clinical assessment of volume status, weight measurement, and BNP assessment. In the event that repeat BNP or NT-proBNP labs have not been drawn within 72 hours of discharge, study staff will coordinate with the pathology laboratory (Dr. Kent Lewandrowski) to perform the assay as a research test using excess clinical specimen from the subject's routine clinical blood draw if available. Research subjects will not be charged for the cost of the BNP or NT-Pro-BNP assay.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doppler ultrasound | Experimental | Device: Recording Doppler ultrasound signals noninvasivelyUsing ultrasound noninvasively and recording Doppler signals from the right chest wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Phase 1(ED):
- 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):
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording Doppler ultrasound signals noninvasivelyUsing ultrasound noninvasively and recording Doppler signals from the right chest wall | Device | Doppler ultrasound |
Primary outcome
Number of patients identified with COPD (or CHF) in comparison to physician diagnosis
Time frame: 1y
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maulik Majmudar, Dr principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording Doppler ultrasound signals noninvasively in people with Dyspnea and Acute Decompensated Heart Failure, run by Echosense Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients identified with COPD (or CHF) in comparison to physician diagnosis (time frame: 1y). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.