Cardiac EchographyEPICNCT03011073
Evaluation of New Items in Cardiac Echography
An observational study of Cardiac Echography and Cardiac Ultrasound, run by Fondation Hôpital Saint-Joseph.
Trial summary
Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system has image processing and left ventricular function quantification software which are different from the precedent model Philips IE33.Left ventricular function quantification and myocardial distortion are the main medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Echography, Cardiac Ultrasound
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 6 Oct 2018
- 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: All patient who have prescription to do an cardiac ultrasound
Who may be able to join
- patient accepting to stay 15 min more
- Age > 18 years old
Who cannot join
- patient not accepting this procedure
About this study
Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system has image processing and left ventricular function quantification software which are different from the precedent model Philips IE33.Left ventricular function quantification and myocardial distortion are the main medical examination influencing doctor's decisions.
EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial distortion quantification software also has been modified with new cut off and different calculation method.
The aim of this study is to compare the quality of images and the quantification of cardiac ejection fraction with these new software in order to choose the more reliable and reproducible for patient.
- Conditions
- Cardiac Echography, Cardiac Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac left ejection fraction
Evaluation of left ejection fraction by 3D
Measured: Day 1
Secondary outcomes (1)
Echographic images evaluation
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start1 Oct 2017
- Primary completion1 Oct 2017
- Study completion6 Oct 2018 (estimated)
Why it stopped: investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EchographyStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011073
- Sponsor's protocol ID
- EPIC
- Acronym
- EPIC
- Status last verified
- Sep 2017
- First submitted
- 3 Jan 2017
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Items in Cardiac Echography
- ClinicalTrials.gov ID
- NCT03011073
- Acronym / sponsor ID
- EPIC / EPIC
- Conditions
- Cardiac Echography, Cardiac Ultrasound
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigator decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 6 Oct 2018 (estimated)
- First posted
- 5 Jan 2017 (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.
Paris Saint Joseph hospital has just acquired a new echocardiography EPIC . This new system has image processing and left ventricular function quantification software which are different from the precedent model Philips IE33.Left ventricular function quantification and myocardial distortion are the main medical examination influencing doctor's decisions.
EPIC can evaluate and quantify the cardiac ejection fraction via new software. Myocardial distortion quantification software also has been modified with new cut off and different calculation method.
The aim of this study is to compare the quality of images and the quantification of cardiac ejection fraction with these new software in order to choose the more reliable and reproducible for patient.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient who have prescription to do an cardiac ultrasound
Key inclusion criteria (2 listed)
- patient accepting to stay 15 min more
- Age > 18 years old
Key exclusion criteria (1 listed)
- patient not accepting this procedure
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
Cardiac left ejection fraction
Time frame: Day 1
Evaluation of left ejection fraction by 3D
1 secondary outcome
Echographic images evaluation
Time frame: day 1
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 8 Nov 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Echography and Cardiac Ultrasound, run by Fondation Hôpital Saint-Joseph.
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 2 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Cardiac left ejection fraction (time frame: Day 1). 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 Nov 2017.