跳至主要内容
临床试验/NCT02018835
NCT02018835已完成不适用

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.

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
blood samples

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •Patient claustrophobic,
  • •patient refusing the protocol or the examination

研究组 & 干预措施

patients of an insufficiency organic severe surgical mitrale

Other

干预措施: cardiac echography transthoracic (Device)

insufficiency organic mitrale moderated in severe asymptomatic

Other

干预措施: MRI (Device)

insufficiency organic mitrale moderated in severe asymptomatic

Other

干预措施: cardiac echography transthoracic (Device)

patients of an aortic bicuspidie

Other

干预措施: MRI (Device)

patients of an aortic bicuspidie

Other

干预措施: cardiac echography transthoracic (Device)

Healthy volunteers

Other

干预措施: cardiac echography transthoracic (Device)

patients of an insufficiency organic severe surgical mitrale

Other

干预措施: MRI (Device)

patients of a syndrome of Marfan

Other

干预措施: MRI (Device)

patients of a syndrome of Marfan

Other

干预措施: cardiac echography transthoracic (Device)

Healthy volunteers

Other

干预措施: MRI (Device)

结局指标

主要结局

blood samples

时间窗: 24 MONTHS

to estimate local and regional heterogeneity in aortic functional parameters

次要结局

  • aortic function(24 MONTHS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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