Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000140954
Ethics application status
Approved
Date submitted
21/01/2020
Date registered
12/02/2020
Date last updated
10/06/2022
Date data sharing statement initially provided
12/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Utilization of a portable hand-held electrocardiogram (ECG) monitor for mapping normal heart signals to investigate the optimal placement of insertable cardiac monitors for patient having heart rhythm disorders investigated.
Scientific title
Optimal sensing electrode configuration for enhanced P-wave visibility: implications for new generation insertable cardiac monitor (ICM) for patients being investigated for heart rhythm disorders - ‘Cherchez le P’ study.
Secondary ID [1] 300220 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Rhythm Disorders 315780 0
Condition category
Condition code
Cardiovascular 314064 314064 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surface electrocardiogram (ECG) recordings will be obtained using a holter monitor from participants in sinus rhythm. Holter monitor ECG is a normal routine practice for patients with heart rhythm disorders.
Participants will have ECG electrodes attached to the chest to allow recording of heart signals. This will be performed by trained cardiology technicians of the research team. ECG strips will be obtained from a specific set of vectors at the standard precordial V2/V3 electrode position of a 12-lead ECG. The vector will be varied by
(1st) inter-electrode lengths {45mm vs 75mm},
(2nd) vector orientation {vertical vs oblique 45 degrees from vertical vs oblique 75 degrees from vertical},
(3rd) intercontercostal spacing {normal V2/V3 position vs one intercostal space superior}. Recordings will last 30 seconds each. Recordings for all vectors should be obtained from each participants and the entire observation will last up to 10 minutes on only a single occasion.
Each ECG strip will be analyzed offline and compared for p-wave amplitude by caliper measurement.
Intervention code [1] 316706 0
Diagnosis / Prognosis
Comparator / control treatment
All participants will undergo all the different electrode arrangements and act as their own control. The p-wave amplitude obtained by the shorter electrode spacing (45mm) will be the control for any p-wave measured for the longer electrode spacing (75mm) at each different vector angle and chest position.
Control group
Active

Outcomes
Primary outcome [1] 322594 0
Change in p-wave amplitude as assessed by ECG with different electrode vector spacing .
Timepoint [1] 322594 0
This is a single point data collection study with no intervention and follow-up requirement. All measurements will be pooled at completion of recruitment for analysis.
Secondary outcome [1] 379007 0
Change in p-wave amplitude as assessed by ECG with different angle of electrode vector.
Timepoint [1] 379007 0
This is a single point data collection study with no intervention and follow-up requirement. All measurements will be pooled at completion of recruitment for analysis.
Secondary outcome [2] 379008 0
Change in p-wave amplitude for different physical body composition, assessed by BMI and body fat percentage calculated by Omron Fat Loss Monitor (HBF-306)
Timepoint [2] 379008 0
This is a single point data collection study with no intervention and follow-up requirement. All measurements will be pooled at completion of recruitment for analysis.

Eligibility
Key inclusion criteria
• Participant must be in sinus rhythm (cardiology inpatients will have telemetry ward monitoring to allow rhythm identification for inclusion).
• Cardiac situs solitus.
• Greater than or equal to 18 years of age.
• Able to provide consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unable to provide written informed consent to participate in this study.
• Participating in another clinical research trial which prevents acquisition of surface ECG.
• Cardiac situs inversus or other abnormal cardiac gross displacement.
• Participant not in sinus rhythm.
• Known allergic reaction to ECG electrode dots.

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
Continuous data will be presented as the mean ± SD and compared with 2-tailed Student t tests. Nominal data will be presented as frequencies and percentages and compared by Chi-squared test. Statistical analyses will be performed using SPSS (IBM SPSS Inc, Chicago, IL). A p-value of less than .05 will be used for statistical significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/02/2020
Actual
14/02/2020
Date of last participant enrolment
Anticipated
23/01/2023
Actual
Date of last data collection
Anticipated
23/01/2023
Actual
Sample size
Target
150
Accrual to date
130
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15670 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 29079 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304651 0
Self funded/Unfunded
Name [1] 304651 0
Unfunded
Country [1] 304651 0
Primary sponsor type
Individual
Name
Dr Dennis Lau
Address
Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 305069 0
None
Name [1] 305069 0
None
Address [1] 305069 0
None
Country [1] 305069 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305071 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305071 0
Postal address:
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305071 0
Australia
Date submitted for ethics approval [1] 305071 0
09/01/2020
Approval date [1] 305071 0
23/01/2020
Ethics approval number [1] 305071 0
12672

Summary
Brief summary
Patients with suspected heart rhythm disorders or syncope are often offered insertable cardiac monitors (ICM) for prolonged cardiac rhythm monitoring. Early models required surgical implantation (larger incision, more complicated implant tools) which limited acceptance by physicians and patients. Improved technology allowed miniaturization of ICM size and a simplified insertion method with an “injectable” tool which has increased acceptance. One manufacturer's recommended insertion position for ICM spans the V2–V3 electrocardiogram (ECG) electrode location in an oblique 45 degree angle, although data supporting this recommendation for adequate cardiac sensing is limited to R-wave signal analysis only. We will analyze non-invasive surface ECG recordings from healthy participants to measure the P-wave signal seen at the manufacturer's recommended insertion point and in other locations to find the optimal location for p-wave visualisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99170 0
A/Prof Dennis H. Lau
Address 99170 0
Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 99170 0
Australia
Phone 99170 0
+61 8 8313 9000
Fax 99170 0
Email 99170 0
[email protected]
Contact person for public queries
Name 99171 0
A/Prof Dennis H. Lau
Address 99171 0
Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 99171 0
Australia
Phone 99171 0
+61 8 8313 9000
Fax 99171 0
Email 99171 0
[email protected]
Contact person for scientific queries
Name 99172 0
A/Prof Dennis H. Lau
Address 99172 0
Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000
Country 99172 0
Australia
Phone 99172 0
+61 8 8313 9000
Fax 99172 0
Email 99172 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
Not included in Human Research Ethics Committee application


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
SourceTitleYear of PublicationDOI
EmbaseFactors affecting electrogram sensing in an insertable cardiac monitor: Insights from surface electrocardiogram mapping analysis.2023https://dx.doi.org/10.1016/j.hrthm.2023.05.034
N.B. These documents automatically identified may not have been verified by the study sponsor.