Gilbert Tom, Redfern Julie, Chew Derek P, Atherton John, Hillis Graham, Nicholls Stephen, Brieger David, Rankin Jamie, Lehman Sam, Maiorana Andrew, Budgeon Charley, Cordingley Anne, Robinson Teagan, Briffa Tom
UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia.
Bond University Institute for Evidence-Based Healthcare, Robina, Queensland, Australia.
BMJ Open. 2025 Jul 30;15(7):e094880. doi: 10.1136/bmjopen-2024-094880.
Cardiac rehabilitation after type 1 myocardial infarction (type 1 MI) is an effective but underutilised method of preventing new cardiac events. This study aims to determine whether a programme of personalised cardiac rehabilitation achieves better completion rates compared with a routine outpatient rehabilitation model post-type 1 MI. A secondary aim is to determine any differences in rates of major adverse cardiovascular events at 12 months.
Secondary prevention for all in need (SPAN) is a prospective multisite single-blind comparative effectiveness randomised trial of personalised versus standard outpatient rehabilitation. Five hundred and thirty-two patients with a recent type 1 MI diagnosis will be randomised to either a personalised model of rehabilitation which includes flexibility in the components of rehabilitation and the time and location of contacts, or the standard outpatient model. Exclusion criteria include conditions associated with higher clinical risk to the participant, which introduce confounding to the study or interfere with a participant's ability to comply.The primary study endpoint is the proportion of patients who complete the assigned rehabilitation model. Completion of rehabilitation is defined as participation in ≥80% of all scheduled sessions, in either treatment arm. Assuming a power of 90% and an overall type 1 error of 5%, we expect that 50% of those randomised to usual care will meet the primary endpoint compared with 65% of those on personalised rehabilitation. To detect this difference of 15%, we require a sample size of 478 participants (239 per arm). Accounting for a conservative attrition rate of 10%, the total sample size required is 532.
The trial received ethical approval from the Southern Adelaide Clinical Human Research Ethics Committee (ref. 2022/HRE00071) in September 2022, with an opt-out approach. The findings will be disseminated through peer-reviewed journals.
ACTRN12622000316707.
1型心肌梗死（1型MI）后的心脏康复是预防新的心脏事件的一种有效但未得到充分利用的方法。本研究旨在确定与1型MI后的常规门诊康复模式相比，个性化心脏康复方案是否能实现更高的完成率。次要目的是确定12个月时主要不良心血管事件发生率的任何差异。
“为所有有需要者提供二级预防”（SPAN）是一项前瞻性多中心单盲比较有效性随机试验，比较个性化康复与标准门诊康复。532例近期诊断为1型MI的患者将被随机分配到个性化康复模式（包括康复组成部分、联系时间和地点的灵活性）或标准门诊模式。排除标准包括与参与者临床风险较高相关的情况，这些情况会给研究带来混杂因素或干扰参与者的依从能力。主要研究终点是完成指定康复模式的患者比例。康复完成定义为在任何一个治疗组中参与≥80%的所有预定疗程。假设检验效能为90%，总体I类错误为5%，我们预计随机分配到常规护理组的患者中有50%达到主要终点，而个性化康复组为65%。为了检测这15%的差异，我们需要478名参与者的样本量（每组239名）。考虑到10%的保守失访率，所需的总样本量为532。
该试验于2022年9月获得南阿德莱德临床人类研究伦理委员会的伦理批准（参考号：2022/HRE00071），采用退出式方法。研究结果将通过同行评审期刊发表。
ACTRN12622000316707。
