Chaouat A, Cherifi A, Sitbon O, Girerd N, Zysman M, Faure M, Mandry D, Mercy M, Guillaumot A, Fay R, Marie P-Y, Chabot F
Département de pneumologie, CHRU de Nancy, pôle des spécialités médicales, 54500 Vandoeuvre-lès-Nancy, France; INGRES, EA 7298, université de Lorraine, 54500 Vandoeuvre-lès-Nancy, France.
CIC-IT, CHRU de Nancy, pôle des structures de soutien à la recherche, 54500 Vandœuvre-lès-Nancy, France.
Rev Mal Respir. 2018 Sep;35(7):749-758. doi: 10.1016/j.rmr.2018.01.010. Epub 2018 Jun 23.
Haemodynamic follow up in pulmonary arterial hypertension (PAH) is currently based on right heart catheterisation (RHC). The primary objective of the EVITA study is to compare the use of cardiac magnetic resonance imaging (cMRI) with RHC in the identification of an unfavourable hemodynamic status. The secondary objectives are to determine the role of cMRI in the follow up process. Patients will undergo at diagnosis and at follow up visits both RHC and cMRI. Patients will be followed and treated according to the current guidelines. The primary endpoint will be an unfavourable haemodynamic status defined by cardiac index<2.5L/min/m or a right atrial pressure≥8mm Hg measured with RHC compared with a cardiac index<2.5L/min/m or right ventricle ejection fraction<35% or an absolute decrease of 10% from the previous measurement with cMRI. Exact values of sensitivity, specificity and 95% confidence intervals will be computed. A population of 180 subjects will have a power of 90% with an α risk of 5%. Univariate and multivariate Cox analysis will allow answering to the secondary objectives. We expect to demonstrate that cMRI could be partly used instead of RHC in the follow up of patients with PAH.
目前,肺动脉高压(PAH)的血流动力学随访基于右心导管检查(RHC)。EVITA研究的主要目的是比较心脏磁共振成像(cMRI)与RHC在识别不良血流动力学状态方面的应用。次要目的是确定cMRI在随访过程中的作用。患者在诊断时和随访时均需接受RHC和cMRI检查。患者将按照现行指南进行随访和治疗。主要终点将是由RHC测量的心脏指数<2.5L/分钟/平方米或右心房压力≥8mmHg所定义的不良血流动力学状态,与之相比,cMRI测量的心脏指数<2.5L/分钟/平方米或右心室射血分数<35%,或较前次测量绝对值下降10%。将计算敏感性、特异性和95%置信区间的精确值。180名受试者的样本量将具有90%的检验效能,α风险为5%。单因素和多因素Cox分析将有助于回答次要目的。我们期望证明,在PAH患者的随访中,cMRI可部分替代RHC。