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

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.