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Trial record 66 of 160 for:    Idiopathic Dilated Cardiomyopathy

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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ClinicalTrials.gov Identifier: NCT02018835
Recruitment Status : Unknown
Verified August 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : December 23, 2013
Last Update Posted : August 7, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Tracking Information
First Submitted Date  ICMJE November 26, 2012
First Posted Date  ICMJE December 23, 2013
Last Update Posted Date August 7, 2015
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
blood samples [ Time Frame: 24 MONTHS ]
to estimate local and regional heterogeneity in aortic functional parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02018835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2013)
aortic function [ Time Frame: 24 MONTHS ]
MRI - magnetic resonance imaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Dilated Cardiomyopathy
Intervention  ICMJE
  • Device: MRI
  • Device: cardiac echography transthoracic
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 17, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02018835
Other Study ID Numbers  ICMJE 2012-A01093-40
2012-28 ( Other Identifier: AP HM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille
Principal Investigator: alexis jacquier AP HM
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2015

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