Myocardial DysfunctionECHOPOGNCT03012308
Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium
An observational study of Myocardial Dysfunction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Dysfunction
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2016to 20 Dec 2017
- 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: Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine, aged over 18 years
Who may be able to join
- Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine
Who cannot join
- No consent
- Mitral valve surgery
- severe MI / severe mitral narrowing.
- Absence of POG catheter
- Urgent surgery
- Heart transplant / mechanical assistance
- Classics: minors, pregnant women, guardianship / curatorship / safeguarding,
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Réanimation chirurgicale cardio-vasculaire - NHC
Strasbourg, 67091
Gharib AJOB, MD, 33 3 69 54 97 58, gharib.ajob@chrustrasbourg.fr
Paul-Michel MERTES, MD, PhD, 33 3 69 55 15 78, paul-michel.mertes@chru-strasbourg.fr
About this study
Official title: Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium
As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).
- Conditions
- Myocardial Dysfunction
- Keywords
- Myocardial Dysfunction, left ventricular, mitral valve doppler, mitral ring doppler, ultrasound signs, lung edema
- Medical subject headings
- Pulmonary Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mean values of LAP between the group "high filling pressures" and the group "non-high filling pressures"
Measured: 6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start20 Dec 2016
- Primary completion20 Dec 2017 (estimated)
- Study completion20 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial DysfunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gharib AJOB, MD, Study director, University Hospital, Strasbourg, FrancePaul-Michel MERTES, MD, PhD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012308
- Sponsor's protocol ID
- 6655 - ECHOPOG
- Acronym
- ECHOPOG
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Left Ventricular Filling Pressures in Post-operative Cardiac Surgery: Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium
- ClinicalTrials.gov ID
- NCT03012308
- Acronym / sponsor ID
- ECHOPOG / 6655 - ECHOPOG
- Conditions
- Myocardial Dysfunction
- Keywords
- Myocardial Dysfunction, left ventricular, mitral valve doppler, mitral ring doppler, ultrasound signs, lung edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 20 Dec 2017 (estimated)
- First posted
- 6 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.
As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine, aged over 18 years
Key inclusion criteria (1 listed)
- Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine
Key exclusion criteria (7 listed)
- No consent
- Mitral valve surgery
- severe MI / severe mitral narrowing.
- Absence of POG catheter
- Urgent surgery
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
Compare the mean values of LAP between the group "high filling pressures" and the group "non-high filling pressures"
Time frame: 6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
Gharib AJOB, MD study director
University Hospital, Strasbourg, France
Paul-Michel MERTES, MD, PhD principal investigator
University Hospital, Strasbourg, France
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 Myocardial Dysfunction, run by University Hospital, Strasbourg, France at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 12 May 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gharib AJOB, MD (33 3 69 54 97 58, gharib.ajob@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the mean values of LAP between the group "high filling pressures" and the group "non-high filling pressures" (time frame: 6 postoperative hours of cardiac surgery of patients hospitalized in surgical resuscitation). 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 12 May 2017.