PREDICTive value of aggressive risk factor modification on the occurrence of major cardiovascular events in patients with embolic STROKE: PREDICT-STROKE

The study intervention to be evaluated is aggressive risk factor modification. Risk factors including obesity, hypertension, dyslipidaemia, glucose intolerance/diabetes, obstructive sleep apnoea, physical activity levels, alcohol, and tobacco use will be systematically evaluated in each participant. Each of the relevant risk factors for that given individual is then targeted aggressively. Risk factor modification will be performed in a multidisciplinary clinic with appointments and contact frequency adjusted according to individual needs. These range from 3-monthly formal appointments to weekly contact by phone or email. Participants will receive regular consultation from a doctor or nurse, with or without exercise physiologist input regarding risk factor modification via intensification of management and treatment for hypertension, dyslipidaemia, diabetes/glucose intolerance, obstructive sleep apnoea, overweight or obesity, physical activity levels, smoking and alcohol consumption. At each appointment, goals will be set in order to achieve optimisation of cardiovascular risk factors. Medications will be increased where required, meal plans and exercise regimes will be modified accordingly. Face-to-face interview and/or telephone/video calls will involve an initial assessment and follow-up appointments of 30-60 minutes. Anticoagulation according to standard indications for any atrial fibrillation detected will be prescribed utilising the appropriate oral anticoagulation agent. A structured, motivational, and goal-directed program will be used for weight reduction within scheduled sessions, with encouragement to keep an accurate food and physical activity diary and blood pressure record. Measurements of weight, blood pressure and results from any appropriate re- assessment of tests such as serum cholesterol or glucose will be evaluated at each visit. Participants will be encouraged to utilise support counselling and schedule more frequent reviews as required. In participants with a body mass index (BMI) greater than or equal to 27kg/m2, a meal plan and behaviour modification will be utilised initially for weight reduction. The initial goal is to reduce body weight by 10%. Participants will be encouraged to increase their exercise habits progressively until they reach an initial weekly target volume of at least 150 minutes, with a view to increasing to a final target of 250 minutes. The aim is moderate intensity aerobic exercise (for example brisk walking or other), ideally with some strength work sessions (for example home-based body-weight-based exercises), tailored to individual physical activity/exercise preference patterns. Where progress is not satisfactory, accredited exercise physiologist input will be sought. Any exercise prescription will be initiated according to baseline exercise testing and physical activity profile. Adherence to treatment strategies will be assessed at each visit via comparison of prescribed diet, exercise and medication changes with exercise and food diary. Goals will be set at each visit with intensification of the follow up schedule if progress has not been achieved.