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
  Purpose

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.


Condition Intervention
Dilated Cardiomyopathy
Device: MRI
Device: cardiac echography transthoracic

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • blood samples [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
    to estimate local and regional heterogeneity in aortic functional parameters


Secondary Outcome Measures:
  • aortic function [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
    MRI - magnetic resonance imaging


Estimated Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
patients of an insufficiency organic severe surgical mitrale Device: MRI Device: cardiac echography transthoracic
insufficiency organic mitrale moderated in severe asymptomatic Device: MRI Device: cardiac echography transthoracic
patients of an aortic bicuspidie Device: MRI Device: cardiac echography transthoracic
patients of a syndrome of Marfan Device: MRI Device: cardiac echography transthoracic
Healthy volunteers Device: MRI Device: cardiac echography transthoracic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018835

Contacts
Contact: jacquier alexis 0491388457 alexis.jacquier@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: bernard belaigues    0491382747    dir.recherche@ap-hm.fr   
Principal Investigator: alexis jacquier         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille
Principal Investigator: alexis jacquier AP HM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02018835     History of Changes
Other Study ID Numbers: 2012-A01093-40, 2012-28
Study First Received: November 26, 2012
Last Updated: July 23, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014