Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.
Primary Purpose
Dilated Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
cardiac echography transthoracic
Sponsored by
About this trial
This is an interventional other trial for Dilated Cardiomyopathy
Eligibility Criteria
Inclusion Criteria:
- Autonomous ADULT patient,
patient Marfan:
- under their usual treatment(processing) (including ß blocking)
- diagnosis confirmed by the molecular biology (transfer(transformation) of the gene FBN1)
- Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta on an echocardiography or an imaging in cups(cuttings) dating less than 6 months.
PATIENT Aortic bicuspid :
- Diagnosis confirmed by cardiac echography and/or imaging in cups(cuttings)
- Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta, and absence of valvulopathy aortic significant (IA of rank I in II, absence of significant RA), on the echocardiography or the imaging in cups(cuttings) dating less than 6 months.
patients Insufficiency mitral organic moderated in severe asymptomatic:
- SOR > 30 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months
- Absence of ischemic or functional cause
- Patient recovering from a functional evaluation by echography of effort
patients Insufficiency mitral organic severe surgical
- SOR > 40 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months
- Absence of ischemic or functional cause
- Status functional: stage(stadium) II of the NYHA
- Patient recovering from a functional evaluation by echography of effort
Volunteer healthy :
- affiliated to the Social Security
- having given its agreement by signed consent
- not presenting contraindication to the realization of a MRI
Exclusion Criteria:
- Patient claustrophobic,
- patient refusing the protocol or the examination
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
patients of an insufficiency organic severe surgical mitrale
insufficiency organic mitrale moderated in severe asymptomatic
patients of an aortic bicuspidie
patients of a syndrome of Marfan
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
blood samples
to estimate local and regional heterogeneity in aortic functional parameters
Secondary Outcome Measures
aortic function
MRI - magnetic resonance imaging
Full Information
NCT ID
NCT02018835
First Posted
November 26, 2012
Last Updated
November 9, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02018835
Brief Title
Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.
Official Title
Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 5, 2013 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
October 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Detecting abnormalities in the left ventricular mechanical and hemodynamic response to the stress of exercise may offer early diagnostic indicators in patients suffering from valvular disease such as mitral regurgitation. Ultrasound-based imaging methods have been gaining importance in providing prognosis among those patients. However, decreased signal to noise ratio in the images and increased motion-related artifacts during exercise stress echocardiography have been reported, with a lack of reproducibility of results and a the limitation of its availability only in reference centers. In our laboratory, we are able to perform supine bicycle exercise MRI (1.5 T) using the Lode ergometer mounted on the far end of the patient table, previously described in healthy volunteers.
The first aim of our study is to demonstrate the safety and the feasibility of our MRI protocol in selected patients with asymptomatic severe organic mitral regurgitation, to assess left ventricular volumes and function, and regurgitant volume in comparison to exercise cardiac echography.
Besides, few recent studies sustain the relevance of novel markers of central aortic function (compliance, distensibility and pulse wave velocity) assessed by noninvasive MRI to explore vascular aging. In monogenic connective tissue diseases, altered arterial stiffness is the premature signature of the disease in asymptomatic patients. Noninvasive evaluation of aortic stiffness would be useful for risk assessment and preventive follow-up strategies in young asymptomatic relatives of subjects with aortic inherited diseases, such as syndromic and non-syndromic familial forms of thoracic aortic aneurysm and /or dissection. Furthermore, this technique should be able to evaluate the effect of drugs on aortic stiffness change in trials, before and after drug therapy, more relevant than the classic change in aortic diameter measurement.
The second aim of our study is 1) to provide the sensibility of our MRI protocol to estimate local and regional heterogeneity in aortic functional parameters (distensibility, compliance and PWV) 2) to evaluate the predictive value of these regional aortic parameters assessed by MRI to diagnose and to stratify the aortopathy related to presymptomatic Marfan patients and to bicuspid aortic valve in young adults, in comparison to carotids-femoral pulse wave velocity estimation by applanation tonometry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients of an insufficiency organic severe surgical mitrale
Arm Type
Other
Arm Title
insufficiency organic mitrale moderated in severe asymptomatic
Arm Type
Other
Arm Title
patients of an aortic bicuspidie
Arm Type
Other
Arm Title
patients of a syndrome of Marfan
Arm Type
Other
Arm Title
Healthy volunteers
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Type
Device
Intervention Name(s)
cardiac echography transthoracic
Primary Outcome Measure Information:
Title
blood samples
Description
to estimate local and regional heterogeneity in aortic functional parameters
Time Frame
24 MONTHS
Secondary Outcome Measure Information:
Title
aortic function
Description
MRI - magnetic resonance imaging
Time Frame
24 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Autonomous ADULT patient,
patient Marfan:
under their usual treatment(processing) (including ß blocking)
diagnosis confirmed by the molecular biology (transfer(transformation) of the gene FBN1)
Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta on an echocardiography or an imaging in cups(cuttings) dating less than 6 months.
PATIENT Aortic bicuspid :
Diagnosis confirmed by cardiac echography and/or imaging in cups(cuttings)
Asymptomatic or Dilation of the aorta = 40 mm on the ascending aorta, and absence of valvulopathy aortic significant (IA of rank I in II, absence of significant RA), on the echocardiography or the imaging in cups(cuttings) dating less than 6 months.
patients Insufficiency mitral organic moderated in severe asymptomatic:
SOR > 30 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months
Absence of ischemic or functional cause
Patient recovering from a functional evaluation by echography of effort
patients Insufficiency mitral organic severe surgical
SOR > 40 mm2, on an echocardiography or an imaging in cups(cuttings) dating less than 6 months
Absence of ischemic or functional cause
Status functional: stage(stadium) II of the NYHA
Patient recovering from a functional evaluation by echography of effort
Volunteer healthy :
affiliated to the Social Security
having given its agreement by signed consent
not presenting contraindication to the realization of a MRI
Exclusion Criteria:
Patient claustrophobic,
patient refusing the protocol or the examination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
alexis jacquier
Organizational Affiliation
AP HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Exercise Stress MRI to Evaluate Aortic Function (Compliance, Distensibility, Pulse Wave Velocity) and Left Ventricular Function : Validation in Healthy Volunteers and in Selected Patients. A Pilot Study.
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