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Use of Imaging Endpoints in Clinical Trials. [Review]

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Citation: Jacc: Cardiovascular Imaging. 10(3):296-303, 2017 MarPMID: 28279377Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Cardiac Imaging Techniques | *Cardiovascular Diseases/dg [Diagnostic Imaging] | *Clinical Trials as Topic/mt [Methods] | *Endpoint Determination | *Research Design | Cardiac Imaging Techniques/st [Standards] | Cardiovascular Diseases/th [Therapy] | Clinical Trials as Topic/st [Standards] | Endpoint Determination/st [Standards] | Humans | Observer Variation | Predictive Value of Tests | Reproducibility of Results | Research Design/st [Standards] | United States | United States Food and Drug AdministrationYear: 2017 ISSN:

1876-7591

Name of journal: JACC. Cardiovascular imagingAbstract: Cardiovascular imaging is an integral component of many clinical trials beyond those for which the primary goal is to evaluate or validate imaging technologies. The scope of such trials is broad, ranging from those in which a medical, surgical, or interventional cardiovascular device or drug is being evaluated to those in which there is concern about cardiovascular adverse events complicating treatment for noncardiac conditions. This paper discusses study design as it pertains to the incorporation of imaging elements, the important role played by imaging core laboratories, the rationale for and approaches to involvement of imagers in clinical trials, and guidance by the U.S. Food and Drug Administration on imaging endpoints in clinical trials.Copyright � 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.All authors: Gillam LD, Leipsic J, Weissman NJFiscal year: FY2017Digital Object Identifier:

https://dx.doi.org/10.1016/j.jcmg.2016.12.003

Date added to catalog: 2017-05-06

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Title notes ( 3 )

Holdings
Item type	Current library	Collection	Call number	Status	Date due	Barcode
Journal Article	MedStar Authors Catalog	Article	28279377	Available		28279377

Cardiovascular imaging is an integral component of many clinical trials beyond those for which the primary goal is to evaluate or validate imaging technologies. The scope of such trials is broad, ranging from those in which a medical, surgical, or interventional cardiovascular device or drug is being evaluated to those in which there is concern about cardiovascular adverse events complicating treatment for noncardiac conditions. This paper discusses study design as it pertains to the incorporation of imaging elements, the important role played by imaging core laboratories, the rationale for and approaches to involvement of imagers in clinical trials, and guidance by the U.S. Food and Drug Administration on imaging endpoints in clinical trials.

English