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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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.

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.
    



Study Type

Interventional


Primary Outcome

blood samples

Secondary Outcome

 aortic function

Condition

Dilated Cardiomyopathy

Intervention

MRI

Study Arms / Comparison Groups

 patients of an insufficiency organic severe surgical mitrale
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

90

Start Date

December 2012

Completion Date

July 2016

Primary Completion Date

December 2015

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

BERNARD BELAIGUES, 0491388457, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02018835

Organization ID

2012-A01093-40

Secondary IDs

2012-28

Responsible Party

Sponsor

Study Sponsor

Assistance Publique Hopitaux De Marseille


Study Sponsor

BERNARD BELAIGUES, Study Director, Assistance Publique Hopitaux De Marseille


Verification Date

August 2015