Acute CardiovascularNCT01961141
Evaluation of Lung Doppler Signals in Patients Presenting to EMD
An observational study of Acute Cardiovascular and Pneumonia, run by Echosense Ltd. at 1 site in Israel.
Trial summary
Historically, ultrasound has been unable to provide interpretable data from the lung parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by the air in the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiovascular, Pneumonia, Pulmonary Embolism
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Jun 2015
- Phase
- Observational
- 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
Study population: Patients presenting to the EMD with acute cardiovascular and/or pulmonary conditions, including- but not restricted to- pneumonia, pulmonary embolism, CHF exacerbation, COPD exacerbation, shock, etc.
Who may be able to join
- Men or women aged over 18. Suspected or confirmed acute cardiovascular or pulmonary condition.
Who cannot join
- Minor (aged < 18). People unwilling to give informed consent. Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Lung Doppler Signals in Patients With Acute Cardiovascular or Pulmonary Conditions Presenting to the Emergency Medicine Department by a Modified Ultrasound Doppler TCD Device.
Historically, ultrasound has been unable to provide interpretable data from the lung parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by the air in the lungs. Recently 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 (transthoracic parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. 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.
Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF, COPD and pulmonary hypertension, show promise regarding the diagnostic potential of the lung Doppler signals (unpublished data). However, lung Doppler signals in acute disease states were not investigated so far. It is reasonable to speculate that the pathological processes underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the TPD may have diagnostic potential in these conditions. For example, during acute pulmonary embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable to assume that the LDS will disappear in the affected area, enabling to confirm the diagnosis without using ionizing radiation (as in CT or lung scan). Another example is COPD exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be attenuated by the increase of air volume in the lungs.
Read the detailed description
- Study Purpose and Rationale To evaluate the LDS in patients with various acute cardiovascular and/or pulmonary disease states, in order to characterize these signals and assess their diagnostic utility in those acute conditions.
- Study Design
The study design is an open, prospective, non-interventional study. 100 patients will be recruited at the Rambam Emergency Medicine Department (EMD) during an 18 month period.
Study population will consist of patients presenting to the EMD with acute cardiovascular and/or pulmonary conditions, including- but not restricted to- pneumonia, pulmonary embolism, CHF exacerbation, COPD exacerbation, shock, etc. Following informed consent and applying the inclusion and exclusion criteria, the eligible patients will undergo routine physical examination including vital signs measurement (blood pressure, heart rate, respiratory rate, O2 saturation by pulse oximetry), and auscultation to lungs. The patient would also undergo ECG and chest X-ray as part of the routine evaluation. Blood tests and additional imaging procedures will be done according to clinical indication. Lung Doppler signals will be recorded from selected locations over the right chest wall, preferably in sitting or semi-reclining position (if patient's condition permits). The recordings will be repeated several times in the EMD to monitor the changes following treatment. In some cases, LDS recordings may also be repeated later in the EMD or other hospital wards when the patient recovers from the acute condition (usually towards the end of the hospital stay). The acquired Doppler data will be saved by PC for off-line processing and analysis using the special algorithms that have been developed for this purpose.
The medical charts of enrolled subjects will also be accessed to obtain study specific information. The information that will be collected includes (but is not limited to): date of birth, gender, height, weight, past medical history, medications, physical examination, ECG, blood tests, pulmonary function tests (including spirometry and lung volumes), chest X-ray/CT and Echocardiography results. The results of study tests and procedures will be disclosed to EchoSense Ltd.
Since the study is non-interventional, the TPD recordings will not be used to guide medical treatment decisions. TPD recordings will not interfere with administering optimal treatment to the patient, which is of first priority in all recruited subjects.
- Study Device The lung Doppler signals will be acquired by the Sonara/tek Transcranial Doppler (TCD) system. This commercially available TCD system was approved by the Federal Drug Administration on November 3rd, 2006 as a 510k class II device. This device was approved as a means of measuring blood flow velocities within the brain as well as peripheral blood vessels. We will utilize this non-invasive Doppler system in an investigational manner to record the lung Doppler signals. The recorded signals will later be analyzed by the EchoSense signal processing package.
- Keywords
- Ultrasound Doppler, Pulmonary diseases, Cardiopulmonary conditions
- Medical subject headings
- Pneumonia, Pulmonary Embolism, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose irregular pattern of lung Doppler signals recorded in patients by features as velocity, power ect in comparison to control pattern
Measured: 1.5y to collect all data required to obtain a diagnostic pattern
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionJun 2015
Why it stopped: review the study concept
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CardiovascularStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Echosense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomo Israelit, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961141
- Sponsor's protocol ID
- DOP17
- Status last verified
- May 2013
- First submitted
- 6 Oct 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lung Doppler Signals in Patients With Acute Cardiovascular or Pulmonary Conditions Presenting to the Emergency Medicine Department by a Modified Ultrasound Doppler TCD Device.
- ClinicalTrials.gov ID
- NCT01961141
- Acronym / sponsor ID
- DOP17
- Keywords
- Ultrasound Doppler, Pulmonary diseases, Cardiopulmonary conditions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: review the study concept
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Echosense Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Oct 2013 (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 has been unable to provide interpretable data from the lung parenchyma, mainly because of the high total ultrasound energy attenuation and scattering by the air in the lungs. Recently 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 (transthoracic parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. 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.
Preliminary data from ongoing studies employing the TPD in chronic diseases such as CHF, COPD and pulmonary hypertension, show promise regarding the diagnostic potential of the lung Doppler signals (unpublished data). However, lung Doppler signals in acute disease states were not investigated so far. It is reasonable to speculate that the pathological processes underlying acute cardiovascular and pulmonary diseases will affect the LDS. Therefore, the TPD may have diagnostic potential in these conditions. For example, during acute pulmonary embolism a portion of the pulmonary vascular system is occluded; therefore it's reasonable to assume that the LDS will disappear in the affected area, enabling to confirm the diagnosis without using ionizing radiation (as in CT or lung scan). Another example is COPD exacerbation, during which there is usually air trapping in the lungs; thus, the LDS may be attenuated by the increase of air volume in the lungs.
Detailed description
- Study Purpose and Rationale To evaluate the LDS in patients with various acute cardiovascular and/or pulmonary disease states, in order to characterize these signals and assess their diagnostic utility in those acute conditions.
- Study Design
The study design is an open, prospective, non-interventional study. 100 patients will be recruited at the Rambam Emergency Medicine Department (EMD) during an 18 month period.
Study population will consist of patients presenting to the EMD with acute cardiovascular and/or pulmonary conditions, including- but not restricted to- pneumonia, pulmonary embolism, CHF exacerbation, COPD exacerbation, shock, etc. Following informed consent and applying the inclusion and exclusion criteria, the eligible patients will undergo routine physical examination including vital signs measurement (blood pressure, heart rate, respiratory rate, O2 saturation by pulse oximetry), and auscultation to lungs. The patient would also undergo ECG and chest X-ray as part of the routine evaluation. Blood tests and additional imaging procedures will be done according to clinical indication. Lung Doppler signals will be recorded from selected locations over the right chest wall, preferably in sitting or semi-reclining position (if patient's condition permits). The recordings will be repeated several times in the EMD to monitor the changes following treatment. In some cases, LDS recordings may also be repeated later in the EMD or other hospital wards when the patient recovers from the acute condition (usually towards the end of the hospital stay). The acquired Doppler data will be saved by PC for off-line processing and analysis using the special algorithms that have been developed for this purpose.
The medical charts of enrolled subjects will also be accessed to obtain study specific information. The information that will be collected includes (but is not limited to): date of birth, gender, height, weight, past medical history, medications, physical examination, ECG, blood tests, pulmonary function tests (including spirometry and lung volumes), chest X-ray/CT and Echocardiography results. The results of study tests and procedures will be disclosed to EchoSense Ltd.
Since the study is non-interventional, the TPD recordings will not be used to guide medical treatment decisions. TPD recordings will not interfere with administering optimal treatment to the patient, which is of first priority in all recruited subjects.
- Study Device The lung Doppler signals will be acquired by the Sonara/tek Transcranial Doppler (TCD) system. This commercially available TCD system was approved by the Federal Drug Administration on November 3rd, 2006 as a 510k class II device. This device was approved as a means of measuring blood flow velocities within the brain as well as peripheral blood vessels. We will utilize this non-invasive Doppler system in an investigational manner to record the lung Doppler signals. The recorded signals will later be analyzed by the EchoSense signal processing package.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the EMD with acute cardiovascular and/or pulmonary conditions, including- but not restricted to- pneumonia, pulmonary embolism, CHF exacerbation, COPD exacerbation, shock, etc.
Key inclusion criteria (1 listed)
- Men or women aged over 18. Suspected or confirmed acute cardiovascular or pulmonary condition.
Key exclusion criteria (1 listed)
- Minor (aged < 18). People unwilling to give informed consent. Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnose irregular pattern of lung Doppler signals recorded in patients by features as velocity, power ect in comparison to control pattern
Time frame: 1.5y to collect all data required to obtain a diagnostic pattern
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Shlomo Israelit, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Cardiovascular and Pneumonia, run by Echosense Ltd. at 1 site in Israel.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 13 Aug 2015. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Diagnose irregular pattern of lung Doppler signals recorded in patients by features as velocity, power ect in comparison to control pattern (time frame: 1.5y to collect all data required to obtain a diagnostic pattern). 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 13 Aug 2015.