Diastolic Dysfunction and Cardiac StiffnessREA-FONCT02051920
Cardiac Elastography Measurement : an Intraoperative Cardiac Surgery Study
An observational study of Diastolic Dysfunction and Cardiac Stiffness, run by University Hospital, Caen at 1 site in France.
Trial summary
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist. We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diastolic Dysfunction and Cardiac Stiffness
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2014
- How long will I take part?
- 1 Month
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing cardiac surgery
Who may be able to join
- Written consent
- Patients older than 18 years
- Every patient scheduled for cardiac surgery
- Cardiac catheterization within 6 months before surgery,
- Women of childbearing age in effective contraception (a urine pregnancy test will be performed)
- Patient affiliated or covered by a plan of health insurance.
- Francophone
Who cannot join
- Pregnant or lactating woman,
- Functional walking disability,
- Patient placed under judicial protection: guardianship,
- Patient participating in another trial and / or participated in another trial within two months,
- Patient under guardianship or trusteeship,
- Women who are not effective contraception,
- Patient with no liberty by administrative or judicial decision
Trial locations and contacts
1 site in 1 country.
Fabrice Bauer, MD,PhD contact
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, Basse Normandie, 14033
Eric saloux, MD
About this study
Official title: Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.
We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.
This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.
The purpose of this study is to evaluate the stiffness during open heart surgery.
- Keywords
- Elastography
What is being measured
The primary outcome is the main question the study is designed to answer.
Young's Modulus measurement according to the equation E = Young 3ρCs ²
Ultrasound acquisition will be completed in epicardial vue using a linear probe SuperLinear 15-4 ™ connected to an ultrasound (AixplorerTM ® from Supersonic Imagine). The acquisitions will be completed in mode B + Elastrography Shear Wave ™ (SWE). A sterile gel is deposited in the bottom of the pouch of sterile protection of the probe. Many measurements will be done on accessible left and right ventricle areas.
Measurement of Young's modulus: automated by the onboard model according to the equation E = Young 3ρCs ², where E is the Young's elastic modulus software, ρ is the tissue density and Cs the velocity of shear wave
Measured: During herat surgery (Day 0)
Secondary outcomes (1)
diastolic function parameters
Correlation between young's modulus and diastolic function parameters is assess after surgery by post processing
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic Dysfunction and Cardiac StiffnessStudies 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen
- Responsible party
- Sponsor
- Investigators
- Fabrice Bauer, MD,PhD, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051920
- Sponsor's protocol ID
- REA-FO-2013-A00593-42
- Acronym
- REA-FO
- Status last verified
- Jan 2015
- First submitted
- 25 Oct 2013
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cardiac Elastography: an Intraoperative Cardiac Surgery Study. Cardiac Elastography in Vivo
- ClinicalTrials.gov ID
- NCT02051920
- Acronym / sponsor ID
- REA-FO / REA-FO-2013-A00593-42
- Keywords
- Elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- University Hospital, Rouen
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- First posted
- 31 Jan 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.
Since 20 years, the techniques of direct measurement of cardiac stiffness in the diagnosis of myocardial diseases do not exist.
We propose a human study evaluating the direct measurement of cardiac ultrasound stiffness by elastography.
This study will include 30 patients with cardiac disease whose rigidity varies with underlying disease.
The purpose of this study is to evaluate the stiffness during open heart surgery.
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing cardiac surgery
Key inclusion criteria (7 listed)
- Written consent
- Patients older than 18 years
- Every patient scheduled for cardiac surgery
- Cardiac catheterization within 6 months before surgery,
- Women of childbearing age in effective contraception (a urine pregnancy test will be performed)
Key exclusion criteria (7 listed)
- Pregnant or lactating woman,
- Functional walking disability,
- Patient placed under judicial protection: guardianship,
- Patient participating in another trial and / or participated in another trial within two months,
- Patient under guardianship or trusteeship,
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
Young's Modulus measurement according to the equation E = Young 3ρCs ²
Time frame: During herat surgery (Day 0)
Ultrasound acquisition will be completed in epicardial vue using a linear probe SuperLinear 15-4 ™ connected to an ultrasound (AixplorerTM ® from Supersonic Imagine). The acquisitions will be completed in mode B + Elastrography Shear Wave ™ (SWE). A sterile gel is deposited in the bottom of the pouch of sterile protection of the probe. Many measurements will be done on accessible left and right ventricle areas. Measurement of Young's modulus: automated by the onboard model according to the equation E = Young 3ρCs ², where E is the Young's elastic modulus software, ρ is the tissue density and Cs the velocity of shear wave
1 secondary outcome
diastolic function parameters
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Fabrice Bauer, MD,PhD contact
Fabrice Bauer, MD,PhD study director
University Hospital, Rouen
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 Diastolic Dysfunction and Cardiac Stiffness, run by University Hospital, Caen 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 7 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 Jan 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 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 Eric Saloux, MD (+330231064901, saloux-e@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Young's Modulus measurement according to the equation E = Young 3ρCs ² (time frame: During herat surgery (Day 0)). 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 Jan 2015.