Abstract

Background

An abdominal aortic aneurysm (AAA) is a focal dilation of the abdominal aorta and is associated with a risk of fatal rupture. Experimental studies suggest that myo-inositol may exert beneficial effects on AAAs through favourable changes to biological pathways implicated in AAA pathology. The aim of the Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN) trial is to assess if myo-inositol will reduce AAA growth.

Methods/design

IMAGEN is a multi-centre, prospective, parallel-group, randomised, double-blind, placebo-controlled trial. A total of 164 participants with an AAA measuring ≥ 30 mm will be randomised to either 2 g of myo-inositol or identical placebo twice daily for 12 months. The primary outcome measure will be AAA growth estimated by increase in total infrarenal aortic volume measured on computed tomographic scans. Secondary outcome measures will include AAA diameter assessed by computed tomography and ultrasound, AAA peak wall stress and peak wall rupture index, serum lipids, circulating AAA biomarkers, circulating RNAs and health-related quality of life. All analysis will be based on the intention-to-treat principle at the time of randomisation. All patients who meet the eligibility criteria, provide written informed consent and are enrolled in the study will be included in the primary analysis, regardless of adherence to dietary allocation.

Discussion

Currently, there is no known medical therapy to limit AAA progression. The IMAGEN trial will be the first randomised trial, to our knowledge, to assess the value of myo-inositol in limiting AAA growth.

Trial registration

Australian New Zealand Clinical Trials Registry, ACTRN12615001209583. Registered on 6 November 2015.

Details

Title
Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): study protocol for a randomised controlled trial
Author
Rowbotham, Sophie E. 1 ; Pinchbeck, Jenna L. 2 ; Anderson, Georgina 2 ; Bourke, Bernie 3 ; Bourke, Michael 4 ; Gasser, T. Christian 5 ; Jaeggi, Rene 2 ; Jenkins, Jason S. 6 ; Moran, Corey S. 2 ; Morton, Susan K. 2 ; Reid, Christopher M. 7 ; Velu, Ramesh 8 ; Yip, Lisan 2 ; Moxon, Joseph V. 2 ; Golledge, Jonathan 8   VIAFID ORCID Logo 

1  The University of Queensland, School of Medicine, Herston, Australia (GRID:grid.1003.2) (ISNI:0000 0000 9320 7537); The Royal Brisbane and Women’s Hospital, Department of Vascular Surgery, Herston, Australia (GRID:grid.416100.2) (ISNI:0000 0001 0688 4634); College of Medicine and Dentistry, James Cook University, Queensland Research Centre for Peripheral Vascular Disease, Townsville, Australia (GRID:grid.1011.1) (ISNI:0000 0004 0474 1797) 
2  College of Medicine and Dentistry, James Cook University, Queensland Research Centre for Peripheral Vascular Disease, Townsville, Australia (GRID:grid.1011.1) (ISNI:0000 0004 0474 1797) 
3  Gosford Vascular Services, Gosford, Australia (GRID:grid.1011.1) 
4  College of Medicine and Dentistry, James Cook University, Queensland Research Centre for Peripheral Vascular Disease, Townsville, Australia (GRID:grid.1011.1) (ISNI:0000 0004 0474 1797); Gosford Vascular Services, Gosford, Australia (GRID:grid.1011.1) 
5  School of Engineering Sciences, KTH Royal Institute of Technology, Department of Solid Mechanics, Stockholm, Sweden (GRID:grid.5037.1) (ISNI:0000000121581746) 
6  The Royal Brisbane and Women’s Hospital, Department of Vascular Surgery, Herston, Australia (GRID:grid.416100.2) (ISNI:0000 0001 0688 4634) 
7  Curtin University, School of Public Health, Perth, Australia (GRID:grid.1032.0) (ISNI:0000 0004 0375 4078); Monash University, School of Public Health and Preventive Medicine, Melbourne, Australia (GRID:grid.1002.3) (ISNI:0000 0004 1936 7857) 
8  College of Medicine and Dentistry, James Cook University, Queensland Research Centre for Peripheral Vascular Disease, Townsville, Australia (GRID:grid.1011.1) (ISNI:0000 0004 0474 1797); The Townsville Hospital, Department of Vascular and Endovascular Surgery, Townsville, Australia (GRID:grid.417216.7) (ISNI:0000 0000 9237 0383) 
Pages
547
Publication year
2017
Publication date
Dec 2017
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-017-2304-x
ProQuest document ID
2795264539
Copyright
© The Author(s). 2017. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.