Impact of an intensive lifestyle program on low attenuation plaque and myocardial perfusion in coronary heart disease: A randomised clinical trial protocol

Q3 Medicine

Nutrition and Healthy Aging Pub Date : 2022-07-07 DOI:10.3233/nha-210146

Sophie Cassidy, C. Kroeger, Tian Wang, Sayan Mitra, Chen Liu, R. Ribeiro, Aimee Dai, Jonathan Lau, Robin Huang, Andrius Masedunkas, Shane Jose, Na Liu, L. Avery, Jessica Yang, M. McGrady, Serigne N. Lô, Jacob George, P. Cistulli, L. Khor, R. Kozor, M. Ugander, I. Wilcox, I. Hunyor, L. Fontana

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引用次数: 2

Abstract

IMPORTANCE: The evidence that maintaining a healthy body weight in conjunction with healthier eating patterns, exercise training and reduced stress can improve clinical outcomes in patients with atherosclerotic cardiovascular disease is substantial. However, little is known about the magnitude and temporal effects of a comprehensive lifestyle treatment on coronary artery anatomy, myocardial inflammation, and fibrosis in people affected by coronary heart disease. OBJECTIVE: To conduct a randomised clinical trial to determine the impact of a 12-month intense lifestyle intervention delivered by an e-Health mobile App versus standard clinical care on low attenuation plaque volume and structure, stress myocardial perfusion, and diastolic function. DESIGN: A single centre, parallel-group, randomised controlled trial. The co-primary endpoints are: 1-Low Attenuation Plaque (LAP) volume (mm3) using coronary computed tomography angiography (CCTA) at 12 months, and 2-Adenosine stress myocardial blood flow (stress MBF, mL/min/g) using cardiovascular magnetic resonance imaging (MRI) at 12 months. Other key measurements include liver steatosis by MRI, subclinical abnormalities detected by advanced electrocardiography, arterial stiffness, endothelial function, and genomic, metabolomic, and gut microbiome-related adaptations to these structural changes. An intention-to-treat principle will be used for all analyses. SETTING: Participants will be recruited from a large academic cardiology office practice (Central Sydney Cardiology) and Royal Prince Alfred Hospital (RPAH) Departments of Cardiology and Radiology. All clinical investigations will be undertaken within the Charles Perkins Centre-RPAH clinic. PARTICIPANTS: Individuals (n = 150) with stable coronary heart disease who have low attenuation plaque based on a CCTA within the past 3 months, will be randomised to a lifestyle intervention program comprising a 5:2 pesco-vegetarian diet, exercise training, and mindfulness-based stress reduction (n = 75) or usual care (n = 75). DISCUSSION: This trial will represent the single most detailed and integrated analysis of the effects of a comprehensive lifestyle intervention targeting multiple metabolic pathways, delivered via a customized e-Health App on smart devices, on coronary macro- and microcirculation, heart physiology and cardiometabolic risk. It will provide a new framework for allowing clinicians and individuals to optimise metabolic health for the prevention and management of atherosclerotic cardiovascular diseases that is epidemic in modern society.

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强化生活方式对冠心病低衰减斑块和心肌灌注的影响:一项随机临床试验方案

重要性:有大量证据表明，保持健康的体重，结合健康的饮食模式、运动训练和减轻压力，可以改善动脉粥样硬化性心血管疾病患者的临床结果。然而，人们对综合生活方式治疗对冠心病患者冠状动脉解剖、心肌炎症和纤维化的影响程度和时间知之甚少。目的:开展一项随机临床试验，以确定由电子健康移动应用程序提供的12个月高强度生活方式干预与标准临床护理对低衰减斑块体积和结构、应激心肌灌注和舒张功能的影响。设计:单中心、平行组、随机对照试验。共同的主要终点是:1- 12个月时冠状动脉计算机断层血管造影(CCTA)的低衰减斑块(LAP)体积(mm3)， 2- 12个月时心血管磁共振成像(MRI)的腺苷应激心肌血流量(应激MBF, mL/min/g)。其他关键测量包括MRI检测的肝脂肪变性、高级心电图检测的亚临床异常、动脉僵硬度、内皮功能以及基因组、代谢组学和肠道微生物组对这些结构变化的相关适应。意向处理原则将用于所有分析。环境:参与者将从大型学术心脏病学办公室实践(悉尼中心心脏病学)和皇家阿尔弗雷德王子医院(RPAH)心脏病学和放射科招募。所有临床调查将在查尔斯·珀金斯中心- rpah诊所进行。参与者:根据CCTA，过去3个月内具有低衰减斑块的稳定型冠心病患者(n = 150)将被随机分配到生活方式干预计划中，包括5:2鱼素饮食、运动训练和基于正念的减压(n = 75)或常规护理(n = 75)。讨论:该试验将代表针对多种代谢途径的综合生活方式干预效果的最详细和综合分析，通过智能设备上定制的电子健康应用程序提供，对冠状动脉宏观和微循环，心脏生理和心脏代谢风险。它将为临床医生和个人提供一个新的框架，以优化代谢健康，预防和管理在现代社会流行的动脉粥样硬化性心血管疾病。

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来源期刊

Nutrition and Healthy Aging Agricultural and Biological Sciences-Food Science

CiteScore

1.70

自引率

0.00%

发文量

期刊介绍： Nutrition and Healthy Aging is an international forum for research on nutrition as a means of promoting healthy aging. It is particularly concerned with the impact of nutritional interventions on the metabolic and molecular mechanisms which modulate aging and age-associated diseases, including both biological responses on the part of the organism itself and its micro biome. Results emanating from both model organisms and clinical trials will be considered. With regards to the latter, the journal will be rigorous in only accepting for publication well controlled, randomized human intervention trials that conform broadly with the current EFSA and US FDA guidelines for nutritional clinical studies. The journal will publish research articles, short communications, critical reviews and conference summaries, whilst open peer commentaries will be welcomed.