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Trial registered on ANZCTR
Registration number
ACTRN12625000033448
Ethics application status
Approved
Date submitted
4/10/2024
Date registered
16/01/2025
Date last updated
16/01/2025
Date data sharing statement initially provided
16/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Screening for Aortic Stenosis Using Gyrocardiography (GCG)
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Scientific title
Evaluation of Gyrocardiography as a Diagnostic Screening Tool for Aortic Stenosis: A Phase 1 Trial Assessing Sensitivity and Specificity in a Cohort of 300 Subjects
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Secondary ID [1]
313114
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis
335373
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Condition category
Condition code
Cardiovascular
331949
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
329687
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Diagnosis / Prognosis
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Intervention code [2]
330240
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Treatment: Devices
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Comparator / control treatment
Participants with normal aortic valves will be allocated to control group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Diagnostic accuracy of GCG as a screening tool for the detection of mild-to-moderate or severe AS.
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Assessment method [1]
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The diagnosis obtained from the GCG data will be compared to the results found on echocardiogram using Sensitivity and Specificity Analysis
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Timepoint [1]
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Assessment will be performed once GCG testing has been performed on all recruited patients.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
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Nil
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/02/2025
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Actual
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Date of last participant enrolment
Anticipated
1/06/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Precordior Ltd
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Address [1]
317559
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Country [1]
317559
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Finland
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Primary sponsor type
Government body
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Name
East Metropolitan Health Service
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319862
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Address [1]
319862
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Country [1]
319862
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Royal Perth Hospital Human Research Ethics Committee
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Ethics committee address [1]
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EMHS.REG@health.wa.gov.au.
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/01/2024
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Approval date [1]
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24/01/2024
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Ethics approval number [1]
316269
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Natasha Wende
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Address
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Royal Perth Hospital, 197 Wellington Street Perth WA 6000
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Country
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Australia
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Phone
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+61 433678146
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Natasha Wende
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Address
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Royal Perth Hospital, 197 Wellington Street Perth WA 6000
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Country
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Australia
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Phone
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+61 8 9224 2244
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Fax
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Email
137343
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[email protected]
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Contact person for scientific queries
Name
137344
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Natasha Wende
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Address
137344
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Royal Perth Hospital, 197 Wellington Street Perth WA 6000
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Country
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Australia
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Phone
137344
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+61 433678146
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Fax
137344
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Email
137344
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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