None listed
Conditions
Brief summary
There are 445,000 stroke survivors in Australia and every year there are ~28,000 new strokes. Almost a third of ischemic strokes (the major stroke type), are related to Atrial Fibrillation (AF), an abnormal heart rhythm leading to blood clots in the heart which travel to the brain. 10% of these strokes are due to unknown AF only detected at the time of stroke. Ischemic strokes are potentially preventable by systematic population screening for AF in a setting where preventive treatment can be given. This could significantly reduce stroke burden and cost to society. One in four adults aged over 40 will develop AF in their lifetime. Prevalence and incidence of AF rise sharply with age (over 10% aged greater than and equal to 70 have AF). AF numbers are predicted to double in Australia between 2014 and 2034, even after adjustment for population ageing. It is an important health problem associated with a 5-fold increase in stroke, which is often disabling or fatal. AF is also associated with an increased risk of death, with growing evidence of an association with cognitive decline/dementia which may be reduced by oral anticoagulation, now standard therapy for AF. While AF may give rise to palpitations or other symptoms, often there are no symptoms in older people who are at the highest risk of stroke. Approximately 10% of ischemic strokes occur in people with newly diagnosed asymptomatic AF, which is unlikely to be identified without screening, thus a major opportunity for stroke prevention. The rationale underpinning a strategy of screening is to make an early diagnosis of asymptomatic and under-treated AF, so oral anticoagulants (showing a 64% stroke reduction by preventing cardio-embolism) can be started to prevent AF-related stroke. It is not known whether the screening strategy will be better than usual practice, This is the rational underpinning the the SAFER-AUS study which is a randomised controlled trial with stroke endpoint, where participants randomised to intervention (AF screening) or control (usual practice). We aim to recruit a total of 780 participants from a mixture of urban and rural settings across 3 states, with each practice having a minimum of 500 active registered patients aged greater than or equal to 70 years. The SAFER-AUS trial to screen for unknown AF is a research partnership between Australia and the University of Cambridge.
Interventions
Atrial Fibrillation (AF) Screening will be conducted using a single-lead Zenicor handheld ECG device, which has TGA approval. A 30-second lead-1 ECG is recorded by holding thumbs on the electrodes. ECG traces are not displayed or analysed on the recorder, and are transmitted over a cellular network to the central Zenicor database by pushing the send button. The Zenicor algorithm classifies each ECG trace as ‘possible AF’, ‘no tag’, ‘other deviations’ or ‘poor quality. The Zenicor has 98% sensit
Atrial Fibrillation (AF) Screening will be conducted using a single-lead Zenicor handheld ECG device, which has TGA approval. A 30-second lead-1 ECG is recorded by holding thumbs on the electrodes. ECG traces are not displayed or analysed on the recorder, and are transmitted over a cellular network to the central Zenicor database by pushing the send button. The Zenicor algorithm classifies each ECG trace as ‘possible AF’, ‘no tag’, ‘other deviations’ or ‘poor quality. The Zenicor has 98% sensitivity and 92% specificity, which is ideal for this style of screening due to the low false negative rate. Consented participants will be contacted by the research staff by telephone to alert them package dispatch (~5mins) and a Zenicor ECG device (with user manual) will then be sent to the participant’s home. Research staff will be available for a further phone call or video conference if required to help the participant use the Zenicor ECG. The participant will be requested to record 4 ECGs a day for 3 weeks, plus additional recordings if AF symptoms are experienced. The number of additional recordings will be determined by a cardiologist at the time of review. All recorded ECGs are logged within the Zenicor system for coordinators to track adherence to the outlined uses of the device.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Age greater than or equal to 70 years, with no upper age limit (as recorded on the practice medical record). b) Either: No diagnosis of AF; OR AF diagnosis but not on anticoagulation. c) Have provided informed consent to participate.
Exclusion criteria
a) Long-term anticoagulation therapy for stroke prevention. b) Receiving palliative care or known to be residing in a Nursing home.
Outcome results
None listed