Research has consistently demonstrated that preventive cardiology programs have limited success, and healthy practices among high-risk individuals remain suboptimal. Furthermore, there are no current programmes in Malta that offer support to first-degree relatives of patients with premature coronary heart disease. This internal pilot study will determine the feasibility, acceptability, and potential effectiveness of a preventative intervention. We are conducting a 12-month single-centre, two-armed group randomised controlled trial (RCT), recruiting a sample of 100 asymptomatic first-degree relatives of patients with premature coronary heart disease (CHD). The study seeks to test an evidence-based intervention to reduce modifiable risk and determine its feasibility and acceptability. The Intervention will be delivered at an outpatient office based in a large acute academic hospital. It will comprise risk communication using an online risk calculator, a counselling style adapted from motivational interviewing, and 12 weekly telephone goal reinforcement calls (3 months). Control subjects will receive verbal lifestyle advice only. Feasibility will be assessed through recruitment and retention. Qualitative evaluation interviews will be conducted with a subsample of 24 purposefully selected participants at 12 months. Assessment for risk factor changes will be measured at pre-intervention and 6 and 12 months. Associations between variables will also be assessed descriptively. Preventive cardiology guidelines highlighted the importance of lifestyle interventions, and lifestyle intervention adherence was proven to reduce atherosclerotic cardiovascular disease (ASCVD) risk, regardless of the individual's genetic risk. Preventive cardiology programmes may fail to adequately support persons in modifying risky behaviours, and research demonstrates that healthy practices among high-risk individuals can remain suboptimal. Siblings and offspring of patients with premature CHD are at increased risk of ASCVD. Despite this, there is no process in place for routine screening and support to modify risk. It is hypothesised that participants assigned to the intervention arm will show more cardio-protective lifestyle-related improvement from the baseline than those in the control group. To date, this is the first trial being conducted amongst Maltese first-degree relatives. This study addresses the needed research, and the results will inform a definitive trial. The funding institution is the University of Malta. ISRCTN, ISRCTN21559170 ; Registered 06/08/2020,

中文翻译：

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对早发冠心病患者的兄弟姐妹和后代进行冠心病风险降低干预：随机对照试验研究的 CRISO 研究方案

研究一致表明，预防性心脏病学计划的成功有限，高危人群的健康实践仍然不理想。此外，马耳他目前没有为早发冠心病患者的一级亲属提供支持的计划。这项内部试点研究将确定预防性干预的可行性、可接受性和潜在有效性。我们正在进行一项为期 12 个月的单中心、两组随机对照试验 (RCT)，招募了 100 名早发冠心病 (CHD) 患者的无症状一级亲属作为样本。该研究旨在测试以证据为基础的干预措施，以降低可改变的风险并确定其可行性和可接受性。干预将在位于一家大型急性学术医院的门诊办公室进行。它将包括使用在线风险计算器进行风险交流、改编自动机访谈的咨询方式以及每周 12 次电话目标强化电话（3 个月）。对照受试者将仅接受口头生活方式建议。将通过招聘和保留来评估可行性。定性评估访谈将在 12 个月时对 24 名有意选择的参与者进行子样本。风险因素变化的评估将在干预前和第 6 个月和第 12 个月进行测量。变量之间的关联也将被描述性地评估。预防心脏病学指南强调了生活方式干预的重要性，生活方式干预的依从性被证明可以降低动脉粥样硬化性心血管疾病 (ASCVD) 的风险，无论个体的遗传风险如何。预防性心脏病学计划可能无法充分支持人们改变危险行为，研究表明，高危人群的健康做法可能仍不理想。早发冠心病患者的兄弟姐妹和后代患 ASCVD 的风险增加。尽管如此，还没有进行常规筛查和支持以修改风险的流程。假设分配到干预组的参与者将比对照组的参与者表现出比基线更多的与心脏保护生活方式相关的改善。迄今为止，这是在马耳他一级亲属中进行的首次试验。这项研究解决了所需的研究，结果将告知最终的试验。资助机构是马耳他大学。ISRCTN, ISRCTN21559170 ; 2020 年 6 月 8 日注册，