Cardiac DiseaseNCT02141269
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)
An observational study of Cardiac Disease, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inpatient and outpatient subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
Who may be able to join
- All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
- Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
- Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
- Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.
Who cannot join
- Subjects who had a limited transthoracic echocardiography (i.e limited views)
- Vscan imaging not attempted for a certain parameter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).
The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
Read the detailed description
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.
We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:
- Ejection fraction: estimates how well the heart is squeezing/functioning.
- Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
- Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
- Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
- Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
- Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
- Pericardial effusion: excessive fluid in the sack around the heart.
The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.
A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.
- Conditions
- Cardiac Disease
- Keywords
- Transthoracic echocardiogram, Hand-held Echocardiography
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of HHE and TTE results
Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.
Measured: 1 time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric Topol, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141269
- Sponsor's protocol ID
- 12-5906
- Status last verified
- May 2015
- First submitted
- 28 Jun 2012
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Pocket, Mobile, Hand-held Echocardiography and Conventional Transthoracic Echocardiography in an Inpatient and Outpatient Clinical Setting
- ClinicalTrials.gov ID
- NCT02141269
- Acronym / sponsor ID
- 12-5906
- Conditions
- Cardiac Disease
- Keywords
- Transthoracic echocardiogram, Hand-held Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 May 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.
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).
The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
Detailed description
A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.
We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.
This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:
- Ejection fraction: estimates how well the heart is squeezing/functioning.
- Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
- Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
- Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
- Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
- Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
- Pericardial effusion: excessive fluid in the sack around the heart.
The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.
A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient and outpatient subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
Key inclusion criteria (4 listed)
- All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
- Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
- Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
- Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.
Key exclusion criteria (2 listed)
- Subjects who had a limited transthoracic echocardiography (i.e limited views)
- Vscan imaging not attempted for a certain parameter
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
Comparison of HHE and TTE results
Time frame: 1 time
Comparison of the two modalities includes accuracy, sensitivity, specificity, proportion visualized, and inter-observer variability.
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 20 May 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.
Eric Topol, MD principal investigator
Scripps Health
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 Cardiac Disease, run by Scripps Translational Science Institute 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 4 inclusion and 2 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 20 May 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 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?
Comparison of HHE and TTE results (time frame: 1 time). 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 20 May 2015.