Aortic Valve StenosisRACINENCT02551588
Valvular Aortic Stenosis: Study of Myocardiac Fibrosis by Magnetic Resonance Imagery
An observational study of Aortic Valve Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Valvular aortic stenosis surgery
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Nov 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Valvular Aortic Stenosis with or without surgery (symptomatic patients) or controls
Who may be able to join
- Echocardiography considered as normal and / or age-related
- Patients who have received prior clinical examination
- Patient receiving a social security scheme or entitled, or CMU
- After having giving written informed consent.
- Patients symptomatic with indication of surgery (group surgery) or not
- Normal EKG
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- Echocardiography considered normal and / or age-related
- Patients who have received prior clinical examination
- Patient receiving a french national social security
- After having obtain written informed consent.
- Criteria for non-inclusion
- History of known or detectable infarction on EKG
- Known primary or secondary cardiomyopathy or detectable on echocardiography
- Thoracic radiotherapy or chemotherapy history
- Subject with usual contra-indications of MRI: claustrophobia, metallic objects.
- Patients with significant renal insufficiency with a clearance <90 ml / min estimated by the Cockcroft \& Gault formula.
- Subject who could be planned for 2 CMR within two weeks
Who cannot join
- With one of the following cardiac abnormalities: atrial fibrillation, more than moderate either aortic or mitral valve regurgitation
- Heart valve surgery history (aortic, mitral, tricuspid and pulmonary).
- Indication for cardiac surgery other than on the aortic valve.
- Usual counter-indications of MRI: Pace-maker, defibrillator, metallic objects including gadolinium allergy.
- Patients with severe renal insufficiency with a clearance <30 ml / min estimated by the Cockcroft \& Gault formula.
- Patient who cannot be followed over the duration of a year.
- CONTROLS (healthy volunteers)
Trial locations and contacts
1 site in 1 country.
France1 site
Departement of Radiology, Hopital Europeen Georges Pompidou,
Paris, 75015
About this study
Official title: Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.
Read the detailed description
To validate new markers assessing cardiac fibrosis three groups of subjects were studied in controls subjects and patients with AVS in order to :
- Analyze myocardial fibrosis markers in MRI, the degree of hypertrophy, remodeling and wall shear stress in a control population and in three groups of subjects to RA progressively increasing risk: asymptomatic subjects without symptomatic subjects LV dysfunction, symptomatic patients with LV dysfunction. The factors favoring the appearance of fibrosis observed in MRI will be analyzed on all subjects.
- To validate these fibrosis markers estimated by MRI by histological analysis of biopsies performed in patients undergoing aortic valve replacement.
- Monitoring compliance with the distribution of markers of fibrosis and wall stress estimated on Initial MRI are factors of aggravation or not improved function and / or remodeling remote myocardial. Public hospitals in Paris
- Conditions
- Aortic Valve Stenosis
- Being tested
- Valvular aortic stenosis surgery
- Keywords
- fibrosis, Magnetic resonance imaging
- Medical subject headings
- Aortic Valve Stenosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valvular aortic stenosis surgeryProcedure or surgery
Dilatation of Valvular aortic stenosis
| Study group | Role | What they receive |
|---|---|---|
| Valvular aortic stenosis surgery | Patients with symptomatic AVS had indication for surgery. They were proposed to have per procedure cardiac biopsy.
They were followed when possible one year after surgery. Receives: Procedure: Valvular aortic stenosis surgery | |
| Valvular aortic stenosis without surgery | These patients with asymptomatic AVS had no indication for surgery. They were followed when possible one year after inclusion. | |
| Control subject | Patients without history of cardiac infarction, primary or secondary myocardiopathy or of radiotherapy or chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of myocardial fibrosis in MRI in patients with AVS
Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis
Measured: At one year
Secondary outcomes (2)
comparison of these markers with myocardial histology
Fibrosis estimated by MRI will be compared to fibrosis on myocardial biopsy symptomatic patients with surgery only)
Measured: At inclusion and at one year
Correlation with Doppler Echocardiography Assessment, and wall stress estimate by using both cardiac MR and carotid artery pressure (applanation tonometry)
Correlation of MRI with known markers of ventricular hypertrophy
Measured: At inclusion and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startDec 2012
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie MOUSSEAUX, MD, PhD, Principal investigator, Departement of Radiology, Hopital Europeen Georges Pompidou, Paris, France. Tel: +33 1 56 09 37 09. E-mail: elie.mousseaux@egp.aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551588
- Sponsor's protocol ID
- P081112
- Acronym
- RACINE
- Status last verified
- Jan 2016
- First submitted
- 4 Sep 2015
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT02551588
- Acronym / sponsor ID
- RACINE / P081112
- Conditions
- Aortic Valve Stenosis
- Keywords
- fibrosis, Magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Sep 2015 (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.
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.
Detailed description
To validate new markers assessing cardiac fibrosis three groups of subjects were studied in controls subjects and patients with AVS in order to :
- Analyze myocardial fibrosis markers in MRI, the degree of hypertrophy, remodeling and wall shear stress in a control population and in three groups of subjects to RA progressively increasing risk: asymptomatic subjects without symptomatic subjects LV dysfunction, symptomatic patients with LV dysfunction. The factors favoring the appearance of fibrosis observed in MRI will be analyzed on all subjects.
- To validate these fibrosis markers estimated by MRI by histological analysis of biopsies performed in patients undergoing aortic valve replacement.
- Monitoring compliance with the distribution of markers of fibrosis and wall stress estimated on Initial MRI are factors of aggravation or not improved function and / or remodeling remote myocardial. Public hospitals in Paris
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valvular aortic stenosis surgery | – | Procedure: Valvular aortic stenosis surgeryPatients with symptomatic AVS had indication for surgery. They were proposed to have per procedure cardiac biopsy. They were followed when possible one year after surgery. |
| Valvular aortic stenosis without surgery | – | –These patients with asymptomatic AVS had no indication for surgery. They were followed when possible one year after inclusion. |
| Control subject | – | –Patients without history of cardiac infarction, primary or secondary myocardiopathy or of radiotherapy or chemotherapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Valvular Aortic Stenosis with or without surgery (symptomatic patients) or controls
Key inclusion criteria (17 listed)
- Echocardiography considered as normal and / or age-related
- Patients who have received prior clinical examination
- Patient receiving a social security scheme or entitled, or CMU
- After having giving written informed consent.
- Patients symptomatic with indication of surgery (group surgery) or not
Key exclusion criteria (7 listed)
- With one of the following cardiac abnormalities: atrial fibrillation, more than moderate either aortic or mitral valve regurgitation
- Heart valve surgery history (aortic, mitral, tricuspid and pulmonary).
- Indication for cardiac surgery other than on the aortic valve.
- Usual counter-indications of MRI: Pace-maker, defibrillator, metallic objects including gadolinium allergy.
- Patients with severe renal insufficiency with a clearance <30 ml / min estimated by the Cockcroft \& Gault formula.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valvular aortic stenosis surgeryDilatation of Valvular aortic stenosis | Procedure or surgery | Valvular aortic stenosis surgery |
Primary outcome
prevalence of myocardial fibrosis in MRI in patients with AVS
Time frame: At one year
Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis
2 secondary outcomes
comparison of these markers with myocardial histology
Time frame: At inclusion and at one year
Correlation with Doppler Echocardiography Assessment, and wall stress estimate by using both cardiac MR and carotid artery pressure (applanation tonometry)
Time frame: At inclusion and at one year
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 25 Jan 2016.
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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.
Elie MOUSSEAUX, MD, PhD principal investigator
Departement of Radiology, Hopital Europeen Georges Pompidou, Paris, France. Tel: +33 1 56 09 37 09. E-mail: elie.mousseaux@egp.aphp.fr
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 Aortic Valve Stenosis, run by Assistance Publique - Hôpitaux de Paris 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 17 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: finished, as of the sponsor's last update on 25 Jan 2016. 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?
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?
prevalence of myocardial fibrosis in MRI in patients with AVS (time frame: At one year). 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 25 Jan 2016.