Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): study protocol for a randomised controlled trial
Rowbotham, Sophie E., Pinchbeck, Jenna L., Anderson, Georgina, Bourke, Bernie, Bourke, Michael, Gasser, T. Christian, Jaeggi, Rene, Jenkins, Jason S., Moran, Corey S., Morton, Susan K., Reid, Christopher M., Velu, Ramesh, Yip, Lisan, Moxon, Joseph V., and Golledge, Jonathan (2017) Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): study protocol for a randomised controlled trial. Trials, 18.
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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.
| Item ID: | 53002 |
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| Item Type: | Article (Research - C1) |
| ISSN: | 1745-6215 |
| Keywords: | Abdominal aortic aneurysm, Inositol, Clinical trial |
| Additional Information: | This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| Funders: | Townsville Hopsital (TH), National Health and Medical Research Council (NHMRC) |
| Projects and Grants: | TH SERTA research grant, NHMRC 1019921, NHMRC 1045862 |
| Date Deposited: | 03 Apr 2018 04:06 |
| FoR Codes: | 32 BIOMEDICAL AND CLINICAL SCIENCES > 3202 Clinical sciences > 320299 Clinical sciences not elsewhere classified @ 100% |
| SEO Codes: | 92 HEALTH > 9299 Other Health > 929999 Health not elsewhere classified @ 100% |
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