Considerations for Clinical Trials Targeting the Myocardial Interstitium

Gavin A. Lewis; Susanna Dodd; Josephine H. Naish; Joseph B. Selvanayagam; Marc R. Dweck; Christopher A. Miller

doi:10.1016/j.jcmg.2019.03.034

Considerations for Clinical Trials Targeting the Myocardial Interstitium

Gavin A. Lewis, Susanna Dodd, Josephine H. Naish, Joseph B. Selvanayagam, Marc R. Dweck, Christopher A. Miller

College of Medicine and Public Health

Research output: Contribution to journal › Review article › peer-review

2 Citations (Scopus)

Abstract

The myocardial interstitium has emerged as a potential therapeutic target and as a biological entity to improve risk stratification and better guide existing interventions. Clinical trials focusing on the myocardial interstitium are required to establish causality and improve patient outcomes. This review will discuss issues around clinical trials targeting the myocardial interstitium, including antifibrotic therapies, efficacy outcome measurements, mechanistic outcome measurements and mediation analysis, sample size, trial duration, considerations for multicenter trials, stratifying trial recruitment according to the interstitium, and approaches to enrich recruitment, using examples of ongoing clinical trials.

Original language	English
Pages (from-to)	2319-2331
Number of pages	13
Journal	JACC: Cardiovascular Imaging
Volume	12
Issue number	11 Pt 2
DOIs	https://doi.org/10.1016/j.jcmg.2019.03.034
Publication status	Published - Nov 2019

Keywords

cardiovascular magnetic resonance
clinical trials
myocardial fibrosis
myocardial interstitium

Access to Document

10.1016/j.jcmg.2019.03.034Licence: In Copyright

Fingerprint Dive into the research topics of 'Considerations for Clinical Trials Targeting the Myocardial Interstitium'. Together they form a unique fingerprint.

Cite this

@article{8a40f7b1a4a94a91aa790ca14b18a3df,

title = "Considerations for Clinical Trials Targeting the Myocardial Interstitium",

abstract = "The myocardial interstitium has emerged as a potential therapeutic target and as a biological entity to improve risk stratification and better guide existing interventions. Clinical trials focusing on the myocardial interstitium are required to establish causality and improve patient outcomes. This review will discuss issues around clinical trials targeting the myocardial interstitium, including antifibrotic therapies, efficacy outcome measurements, mechanistic outcome measurements and mediation analysis, sample size, trial duration, considerations for multicenter trials, stratifying trial recruitment according to the interstitium, and approaches to enrich recruitment, using examples of ongoing clinical trials.",

keywords = "cardiovascular magnetic resonance, clinical trials, myocardial fibrosis, myocardial interstitium",

author = "Lewis, {Gavin A.} and Susanna Dodd and Naish, {Josephine H.} and Selvanayagam, {Joseph B.} and Dweck, {Marc R.} and Miller, {Christopher A.}",

year = "2019",

month = nov,

doi = "10.1016/j.jcmg.2019.03.034",

language = "English",

volume = "12",

pages = "2319--2331",

journal = "JACC: Cardiovascular Imaging",

issn = "1936-878X",

publisher = "Elsevier",

number = "11 Pt 2",

}

TY - JOUR

T1 - Considerations for Clinical Trials Targeting the Myocardial Interstitium

AU - Lewis, Gavin A.

AU - Dodd, Susanna

AU - Naish, Josephine H.

AU - Selvanayagam, Joseph B.

AU - Dweck, Marc R.

AU - Miller, Christopher A.

PY - 2019/11

Y1 - 2019/11

N2 - The myocardial interstitium has emerged as a potential therapeutic target and as a biological entity to improve risk stratification and better guide existing interventions. Clinical trials focusing on the myocardial interstitium are required to establish causality and improve patient outcomes. This review will discuss issues around clinical trials targeting the myocardial interstitium, including antifibrotic therapies, efficacy outcome measurements, mechanistic outcome measurements and mediation analysis, sample size, trial duration, considerations for multicenter trials, stratifying trial recruitment according to the interstitium, and approaches to enrich recruitment, using examples of ongoing clinical trials.

AB - The myocardial interstitium has emerged as a potential therapeutic target and as a biological entity to improve risk stratification and better guide existing interventions. Clinical trials focusing on the myocardial interstitium are required to establish causality and improve patient outcomes. This review will discuss issues around clinical trials targeting the myocardial interstitium, including antifibrotic therapies, efficacy outcome measurements, mechanistic outcome measurements and mediation analysis, sample size, trial duration, considerations for multicenter trials, stratifying trial recruitment according to the interstitium, and approaches to enrich recruitment, using examples of ongoing clinical trials.

KW - cardiovascular magnetic resonance

KW - clinical trials

KW - myocardial fibrosis

KW - myocardial interstitium

UR - http://www.scopus.com/inward/record.url?scp=85073972260&partnerID=8YFLogxK

U2 - 10.1016/j.jcmg.2019.03.034

DO - 10.1016/j.jcmg.2019.03.034

M3 - Review article

C2 - 31422145

AN - SCOPUS:85073972260

VL - 12

SP - 2319

EP - 2331

JO - JACC: Cardiovascular Imaging

JF - JACC: Cardiovascular Imaging

SN - 1936-878X

IS - 11 Pt 2

ER -

Considerations for Clinical Trials Targeting the Myocardial Interstitium

Abstract

Keywords

Access to Document

Other files and links

Cite this