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Rationale and design of the EPLURIBUS Study (Evidence for a comPrehensive evaLUation of left ventRicle dysfnctIon By a whole-heart coverage cardiac compUted tomography Scanner)
Journal of Cardiovascular Medicine ( IF 2.9 ) Pub Date : 2020-10-01 , DOI: 10.2459/jcm.0000000000001051
Daniele Andreini 1, 2 , Edoardo Conte 1 , Saima Mushtaq 1 , Gianluca Pontone 1 , Marco Guglielmo 1 , Andrea Baggiano 1 , Andrea Annoni 1 , Maria E. Mancini 1 , Alberto Formenti 1 , Flavia Nicoli 1 , Alessandra Tanzilli 1 , Giuseppe Muscogiuri 1 , Alessandra Magini 1 , Piergiuseppe Agostoni 1, 2 , Antonio L. Bartorelli 1, 3 , Cesare Fiorentini 1 , Mauro Pepi 1
Affiliation  

Background 

Cardiac magnetic resonance (CMR) is the standard of reference for myocardial fibrosis detection by late gadolinium enhancement. Cardiac computed tomography (CCT) is emerging as a promising alternative. The Evidence for a comPrehensive evaLUation of left ventRicle dysfnctIon By a whole-heart coverage cardiac compUted tomography Scanner study will assess the feasibility and diagnostic accuracy of a comprehensive functional and anatomical cardiac evaluation with CCT as compared with CMR and invasive coronary angiography as standard of reference.

Methods 

Consecutive patients with a newly diagnosed left ventricle (LV) dysfunction (left ventricular ejection fraction <50%) and a clinical indication to CMR will be screened. Exclusion criteria will be contraindications to contrast agents and impaired renal function. CCT will be performed per protocol within 10 days from CMR. A total of 100 patients will be enrolled within 24 months. We will evaluate with CCT volume and ejection fraction of the LV and right ventricle, presence, extent and pattern of delayed enhancement and cardiac venous system. Moreover, presence and degree of coronary stenoses will be evaluated among patients undergoing invasive coronary angiography in the 6 months following CCT.

Results 

The primary study endpoints will be: first, to assess the diagnostic performance of CCT vs. CMR to detect the delayed enhancement in a territory-based and patient-based analysis; second, to assess the agreement between CCT and CMR in the discrimination between ischemic vs. nonischemic delayed enhancement patters in a territory-based analysis; third, to assess the correlation between CCT and CMR for LV and right ventricle end-diastolic and end-systolic volumes and ejection fraction measurements.

Conclusion 

The Evidence for a comPrehensive evaLUation of left ventRicle dysfnctIon By a whole-heart coverage cardiac compUted tomography Scanner study will assess the diagnostic performance of CCT using the latest scanner generation for a comprehensive evaluation of patients with new-onset LV dysfunction.



中文翻译:

EPLURIBUS研究的原理和设计(通过全心覆盖心脏电脑断层扫描仪全面评估左心室功能障碍的证据)

背景 

心脏磁共振(CMR)是晚期late增强检测心肌纤维化的参考标准。心脏计算机断层扫描(CCT)正在成为一种有前途的替代方法。通过全心覆盖心脏计算机断层扫描技术全面评估左心室功能障碍的证据,与CMR和有创冠状动脉造影术相比,使用CCT进行综合功能和解剖学心脏评估的可行性和诊断准确性将作为参考标准。

方法 

将对患有新诊断的左心室(LV)功能障碍(左心室射血分数<50%)和CMR临床适应症的连续患者进行筛查。排除标准是造影剂和肾功能受损的禁忌证。CCT将在CMR生效后的10天内按照协议进行。24个月内将总共招募100名患者。我们将用CCT体积和左心室和右心室的射血分数,延迟增强和心脏静脉系统的存在,程度和模式进行评估。此外,将在CCT后的6个月中对接受有创冠状动脉造影的患者评估冠状动脉狭窄的存在和程度。

结果 

主要的研究终点将是:首先,评估CCT与CMR的诊断性能,以检测基于区域和基于患者的分析中的延迟增强;第二,在基于区域的分析中评估CCT和CMR在区分缺血性与非缺血性延迟增强模式之间的一致性;第三,评估左心室和右心室舒张末期和收缩末期容积和射血分数测量的CCT和CMR之间的相关性。

结论 

通过全心覆盖心脏电脑断层扫描技术全面评估左心室功能障碍的证据扫描仪研究将使用最新一代的扫描仪评估CCT的诊断性能,以全面评估新发左室功能不全的患者。

更新日期:2020-09-11
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