None listed
Conditions
Brief summary
Acute rheumatic fever (ARF) and rheumatic heart disease (RHD) remain an ongoing and preventable cause of heart disease affecting Aboriginal Australians and/or Torres Strait Islander people (hereafter referred to as Indigenous Australians). The diagnosis of ARF is based on the presence of signs or symptoms rather than a definitive investigation. This can lead to instances where the diagnosis is uncertain and diagnostic categories of possible, probable and definite are used. Failure to diagnose ARF accurately is of particular concern given secondary antibiotic prophylaxis is important in the prevention of further ARF as well as progression to RHD-related valvular heart disease. This multi-site research will use cardiac MRI in Alice Springs, Darwin, and Cairns to identify and quantify cardiac inflammation in patients with confirmed or suspected ARF. A score of extent of inflammation will be developed to aid in the diagnosis of ARF, such that more confidence can be placed in the accuracy of diagnosis and therefore the need for ongoing secondary antibiotic prophylaxis. This score will be compared to that of healthy controls and participants with non-ARF inflammatory conditions such as pneumonia. ARF cohort participants will be followed-up at two years to determine if they have subsequently developed RHD (per echocardiogram result). This is to determine whether baseline CMR predicts the future development of RHD (or whether this is dependent on number of antibiotic doses received).
Interventions
There are three participant groups: patients with acute rheumatic fever (ARF), patients with non-ARF inflammatory conditions (e.g. pneumonia, septic arthritis) and healthy controls.
All participants will undergo non-contrast cardiac MRI during their admission (which is in excess of standard care for all participants) at baseline. The scan will take approximately 45 minutes (20 minutes preparation and safety screening, 20-25 minutes scan time). There is no other intervention.
The cardiac MRIs
There are three participant groups: patients with acute rheumatic fever (ARF), patients with non-ARF inflammatory conditions (e.g. pneumonia, septic arthritis) and healthy controls. All participants will undergo non-contrast cardiac MRI during their admission (which is in excess of standard care for all participants) at baseline. The scan will take approximately 45 minutes (20 minutes preparation and safety screening, 20-25 minutes scan time). There is no other intervention. The cardiac MRIs will be undertaken at three sites with MRI scanners capable of performing cardiac MRIs with qualified and experienced radiographers. An audit of 20% of the MRI scans will be undertaken to ensure consistency/satisfactory image quality. With participants permission, their GP and RHD care providers will be informed of their involvement in the study. Since we do not know if the inflammation score measured on MRI is diagnostic or prognostic in the case of ARF (this is what we are trying to determine), it will not be shared with the treating doctor. However, if we find an unexpected abnormality on the scan that requires further investigation/management, the research team will notify your treating team of this with your permission so it can be followed up appropriately. Two years after enrolment, ARF participants will be followed-up with a phone call regarding symptoms, recurrent episodes of ARF, and whether they have received a diagnosis of RHD since enrolment. The most recent echocardiogram result will be used to determine if there has been progression to RHD. ARF participants will be invited to have a repeat MRI (to see if T1 time is the same, longer or shorter than at baseline), however, due to geographical and other barriers, number of participants able to do this is likely to be low.
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
ARF group inclusion - Aged 8 to 35 years - Definite, probable or possible ARF based on the 2020 Australian criteria for ARF diagnosis Non-ARF inflammatory group inclusion - Aged 8 to 35 years - Acute inflammatory/infective condition Control group inclusion - Aged 8 to 35 years - Currently well/healthy
Exclusion criteria
ARF group exclusion criteria - Claustrophobia - Metal implant/object that precludes cardiac MRI - Pregnant or breastfeeding women Non-ARF inflammatory group exclusion criteria - Probable ARF - Any major criteria for ARF - Chest pain - Signs/symptoms of heart failure - History of ARF/RHD - More than mild valvular disease on echocardiogram - Inflammatory condition commonly caused by streptococcal in which no alternate organism has been identified - Known recent/current streptococcal infection (within 6 months of enrolment) - Claustrophobia - Metal implant/object that precludes cardiac MRI - Pregnant or breastfeeding women Control group exclusion - Any infective or inflammatory condition - History of ARF/RHD - More than mild valvular disease on echocardiogram - Known streptococcal infection within 6 months of enrolment - Any major or minor criteria for ARF - Chest pain - Signs or symptoms of heart failure - Claustrophobia - Metal implant/object that precludes cardiac MRI - Pregnant or breastfeeding women
Outcome results
None listed