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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)
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
Secondary ID [1] 313114 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 335373 0
Condition category
Condition code
Cardiovascular 331949 331949 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329687 0
Diagnosis / Prognosis
Intervention code [2] 330240 0
Treatment: Devices
Comparator / control treatment
Participants with normal aortic valves will be allocated to control group.
Control group
Active

Outcomes
Primary outcome [1] 339555 0
Diagnostic accuracy of GCG as a screening tool for the detection of mild-to-moderate or severe AS.
Timepoint [1] 339555 0
Assessment will be performed once GCG testing has been performed on all recruited patients.
Secondary outcome [1] 440424 0
Nil
Timepoint [1] 440424 0
Nil

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317559 0
Commercial sector/Industry
Name [1] 317559 0
Precordior Ltd
Country [1] 317559 0
Finland
Primary sponsor type
Government body
Name
East Metropolitan Health Service
Address
Country
Australia
Secondary sponsor category [1] 319862 0
None
Name [1] 319862 0
Address [1] 319862 0
Country [1] 319862 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316269 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 316269 0
[email protected].
Ethics committee country [1] 316269 0
Australia
Date submitted for ethics approval [1] 316269 0
14/01/2024
Approval date [1] 316269 0
24/01/2024
Ethics approval number [1] 316269 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137342 0
Dr Natasha Wende
Address 137342 0
Royal Perth Hospital, 197 Wellington Street Perth WA 6000
Country 137342 0
Australia
Phone 137342 0
+61 433678146
Fax 137342 0
Email 137342 0
[email protected]
Contact person for public queries
Name 137343 0
Natasha Wende
Address 137343 0
Royal Perth Hospital, 197 Wellington Street Perth WA 6000
Country 137343 0
Australia
Phone 137343 0
+61 8 9224 2244
Fax 137343 0
Email 137343 0
[email protected]
Contact person for scientific queries
Name 137344 0
Natasha Wende
Address 137344 0
Royal Perth Hospital, 197 Wellington Street Perth WA 6000
Country 137344 0
Australia
Phone 137344 0
+61 433678146
Fax 137344 0
Email 137344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.