School of Medicine, The University of Queensland, Herston, QLD, 4006, Australia.
Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, QLD, 4029, Australia.
Trials. 2017 Nov 16;18(1):547. doi: 10.1186/s13063-017-2304-x.
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.
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.
Australian New Zealand Clinical Trials Registry, ACTRN12615001209583 . Registered on 6 November 2015.
腹主动脉瘤（AAA）是腹主动脉的局灶性扩张，与致命性破裂的风险相关。实验研究表明，肌醇可能通过对 AAA 病理相关的生物途径的有利改变，对 AAA 发挥有益作用。Inositol in the MAnaGemENt of abdominal aortic aneurysm（IMAGEN）试验的目的是评估肌醇是否会减少 AAA 的生长。
方法/设计：IMAGEN 是一项多中心、前瞻性、平行组、随机、双盲、安慰剂对照试验。共有 164 名 AAA 测量值≥30mm 的参与者将被随机分为每天两次服用 2g 肌醇或相同安慰剂，持续 12 个月。主要结局指标是通过计算 CT 扫描测量的总肾下主动脉容积的增加来估计 AAA 的生长。次要结局指标包括通过 CT 和超声评估的 AAA 直径、AAA 壁峰值应力和峰值壁破裂指数、血清脂质、循环 AAA 生物标志物、循环 RNA 和健康相关生活质量。所有分析都将基于随机分组时的意向治疗原则。所有符合入选标准、提供书面知情同意并被纳入研究的患者，无论是否遵守饮食分配，都将纳入主要分析。
目前，尚无已知的医学疗法可限制 AAA 的进展。据我们所知，IMAGEN 试验将是第一项评估肌醇在限制 AAA 生长方面价值的随机试验。
澳大利亚新西兰临床试验注册中心，ACTRN12615001209583。于 2015 年 11 月 6 日注册。
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