Society for Cardiovascular Magnetic Resonance (SCMR) expert consensus for CMR imaging endpoints in clinical research: part I - analytical validation and clinical qualification.

Society for Cardiovascular Magnetic Resonance (SCMR) expert consensus for CMR imaging endpoints in clinical research: part I - analytical validation and clinical qualification.
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DOI:
10.1186/s12968-018-0484-5
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发表时间:
2018-09-20
期刊:
Journal of cardiovascular magnetic resonance : official journal of the Society for Cardiovascular Magnetic Resonance
影响因子:
--
通讯作者:
SCMR Clinical Trial Writing Group
SCMR Clinical Trial Writing Group
中科院分区:
其他
文献类型:
--
作者:
Puntmann VO;Valbuena S;Hinojar R;Petersen SE;Greenwood JP;Kramer CM;Kwong RY;McCann GP;Berry C;Nagel E;SCMR Clinical Trial Writing Group

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心血管疾病仍然是全球发病率和死亡率的主要原因。由于对急性病的护理得到改善和人口老龄化,该病的自然史发生了变化,因此需要采取新的战略来应对病程较长和较为缓慢的疾病。这些措施包括增加安全筛查方法的部署,终身监测,以及通过日益个性化的医疗保健监测疾病活动和量身定制的治疗。心血管磁共振(CMR)是一种非侵入性、无电离辐射的方法,可以支持大量临床相关测量,并为推进诊断、预后和治疗的最新技术提供新的机会。SCMR临床试验工作组的目标是总结证据,强调目前cmr指导的临床护理确实可以转化为有意义的使用,有效的资源部署导致有意义和有效的使用。本倡议的目标是对分析验证的证据进行评估,包括准确性和精密度,以及疾病背景下参数的临床资格,澄清最新技术的优势和劣势,以及当前证据中的差距。本文是对现有关于标准化采集和后处理的立场文件的补充,确保了鲁棒性和可转移性,以广泛使用。以成像终点为主题的试验设计指南,以支持药物发现或临床实践中的改变(第二部分),将在适当的时候发表在后续的论文中。由于CMR继续快速发展,预计将定期更新本建议。本文的在线版本(10.1186/s12968-018-0484-5)包含补充材料,可供授权用户使用。
Cardiovascular disease remains a leading cause of morbidity and mortality globally. Changing natural history of the disease due to improved care of acute conditions and ageing population necessitates new strategies to tackle conditions which have more chronic and indolent course. These include an increased deployment of safe screening methods, life-long surveillance, and monitoring of both disease activity and tailored-treatment, by way of increasingly personalized medical care. Cardiovascular magnetic resonance (CMR) is a non-invasive, ionising radiation-free method, which can support a significant number of clinically relevant measurements and offers new opportunities to advance the state of art of diagnosis, prognosis and treatment. The objective of the SCMR Clinical Trial Taskforce was to summarizes the evidence to emphasize where currently CMR-guided clinical care can indeed translate into meaningful use and efficient deployment of resources results in meaningful and efficient use. The objective of the present initiative was to provide an appraisal of evidence on analytical validation, including the accuracy and precision, and clinical qualification of parameters in disease context, clarifying the strengths and weaknesses of the state of art, as well as the gaps in the current evidence This paper is complementary to the existing position papers on standardized acquisition and post-processing ensuring robustness and transferability for widespread use. Themed imaging-endpoint guidance on trial design to support drug-discovery or change in clinical practice (part II), will be presented in a follow-up paper in due course. As CMR continues to undergo rapid development, regular updates of the present recommendations are foreseen. The online version of this article (10.1186/s12968-018-0484-5) contains supplementary material, which is available to authorized users.
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