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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02018835
First received: November 26, 2012
Last updated: July 23, 2014
Last verified: July 2014

November 26, 2012
July 23, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
blood samples [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
to estimate local and regional heterogeneity in aortic functional parameters
Same as current
Complete list of historical versions of study NCT02018835 on ClinicalTrials.gov Archive Site
aortic function [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
MRI - magnetic resonance imaging
Same as current
Not Provided
Not Provided
 
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.
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Dilated Cardiomyopathy
  • Device: MRI
  • Device: cardiac echography transthoracic
  • patients of an insufficiency organic severe surgical mitrale
    Interventions:
    • Device: MRI
    • Device: cardiac echography transthoracic
  • insufficiency organic mitrale moderated in severe asymptomatic
    Interventions:
    • Device: MRI
    • Device: cardiac echography transthoracic
  • patients of an aortic bicuspidie
    Interventions:
    • Device: MRI
    • Device: cardiac echography transthoracic
  • patients of a syndrome of Marfan
    Interventions:
    • Device: MRI
    • Device: cardiac echography transthoracic
  • Healthy volunteers
    Interventions:
    • Device: MRI
    • Device: cardiac echography transthoracic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact: jacquier alexis 0491388457 alexis.jacquier@ap-hm.fr
France
 
NCT02018835
2012-A01093-40, 2012-28
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille
Principal Investigator: alexis jacquier AP HM
Assistance Publique Hopitaux De Marseille
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP