None listed
Conditions
Brief summary
Among strokes resulting from blood vessel blockage leading to sudden damage to the brain (known as ischaemic strokes), just under one third have no underlying cause found despite extensive investigations and most of these are known as embolic stroke of undetermined source (ESUS). To prevent recurrence of these strokes, we hypothesise that intervention to modify risk factors (including being overweight, smoking, diabetes, high blood pressure, high cholesterol, alcohol use, and sleep apnoea) could lead to reduced recurrent strokes and reduced onset of atrial fibrillation (an irregular heart rhythm also known to lead to stroke) in stroke survivors. This risk factor modification, delivered via visits to a specialised risk factor modification clinic, already proven to improve outcomes in atrial fibrillation, will be compared in this study with usual post-stroke medical care. If validated in a separate group of participants without stroke, a special surface ECG’ mapping’ vest will be applied to assess and re-assess the upper heart chamber health of participants with stroke at the beginning and end of this study.
Interventions
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 sought and 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 physician-led clinic with appointments and contact frequency ad
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 sought and 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 physician-led 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 any appropriate intensification of treatment for hypertension, dyslipidaemia, diabetes/glucose intolerance, obstructive sleep apnoea, weight loss, regular exercise, smoking cessation and reduction in alcohol consumption. Intensification of treatment will include medication increase as required, adjustment of meal plans and modified exercise programs. 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. 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%. An accredited exercise physiologist will prescribe regular exercise with a target of 180 minutes per week of moderate aerobic exercise and 30 minutes of home-based resistance training. The exercise prescription will be initiated according to baseline exercise testing and physical activity profile. Participants will be encouraged to increase their exercise habits progressively until they reach the weekly target volume. Adherence to treatment strategies will be assessed at each visit via comparison of prescribed diet, exercise and medication changes with exercise and food diary.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
o Primary diagnosis of ESUS o No history of documented atrial fibrillation or flutter during 24 hours of ward telemetry or ambulatory Holter monitoring o No known history of AF or flutter
Exclusion criteria
o Documented atrial fibrillation or flutter prior to randomisation o Serious Underlying Medical Disorder o Age < 18 o Inability to Provide Informed Consent o Being fully anticoagulated prior to randomisation o Moderate-Severe Valvular Heart disease o Prosthetic Heart Valve o Endocrinopathy including subclinical thyroid disease
Outcome results
None listed