None listed
Conditions
Brief summary
This study aims to evaluate gyrocardiography (GCG) as a diagnostic screening tool that detects the presence of aortic stenosis. GCG data will be obtained from 300 participants with either normal aortic valves or mild, moderate or severe aortic stenosis. The results of the GCG data will be compared to that obtained by echocardiography, the gold standard. We hypothesise that GCG will accurately identify aortic stenosis with high sensitivity and specificity - it will be able to detect patients who truly have the disease, and exclude those that do not. This will benefit patients by improving doctors’ ability to diagnose aortic stenosis and more quickly refer onwards for treatment that may be needed.
Interventions
Prospective, blind comparison to a gold standard.
Participants in this study will be adults who have had an echocardiogram in the preceding 6 months. Based upon echocardiogram results, participants with severe aortic stenosis will be allocated to experimental group 1, patients with mild-moderate aortic stenosis will be allocated to experimental group 2.
Participants attend for a single 20 minute appointment at which time their age, past medical history, transthoracic echocardiogram report and
Prospective, blind comparison to a gold standard. Participants in this study will be adults who have had an echocardiogram in the preceding 6 months. Based upon echocardiogram results, participants with severe aortic stenosis will be allocated to experimental group 1, patients with mild-moderate aortic stenosis will be allocated to experimental group 2. Participants attend for a single 20 minute appointment at which time their age, past medical history, transthoracic echocardiogram report and blood pressure is documented. Gyrocardiography (GCG) data is then obtained using smartphone devices that contain the smartphone application developed by Precordior Ltd. The smartphone device will be placed on the chest over the middle of the sternum and the measurement activated by pressing the “start” button in the CardioSignal application. Four 1-minute recordings will be performed. The intervention will be administered and directly observed by a member of the research team. The GCG data provides a diagnosis which will be compared to the results found on echocardiogram using sensitivity and specific testing. This assessment is performed at Royal Perth Hospital by doctors or research nurses.
Sponsors
East Metropolitan Health Service
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age over 18 years 2. Signed written informed consent to participate in the study 3. For experimental groups 1 and 2, and control group: patients with a confirmed diagnosis of mild-to-moderate, severe AS, or no AS, respectively, determined by transthoracic echocardiography within six months of recruitment date.
Exclusion criteria
1. Inability to provide informed consent 2. Any health problem which, in the opinion of the investigator, prevents the patient from participating in the study (including pregnancy) 3. Aortic valve prosthesis 4. Severe mitral valve disease 5. EF< 30% 6. Presence of an implanted permanent pacemaker (PPM) or implantable cardiac defibrillator (ICD) 7. Low flow low gradient aortic stenosis
Outcome results
None listed