ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiac Rhythm Disorders

Condition category

Condition code

Cardiovascular

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]

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]

Change in p-wave amplitude as assessed by ECG with different electrode vector spacing .

Timepoint [1]

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]

Change in p-wave amplitude as assessed by ECG with different angle of electrode vector.

Timepoint [1]

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]

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]

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)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded

Address [1]

Unfunded

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

Postal address:
Royal Adelaide Hospital
Clinical Trial Centre
Wayfinder 3D460.02
Level 3 
Port Road
ADELAIDE   SA   5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/01/2020

Approval date [1]

23/01/2020

Ethics approval number [1]

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

A/Prof Dennis H. Lau

Address

Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

dennis.lau@adelaide.edu.au

Contact person for public queries

Name

Dennis H. Lau

Address

Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

dennis.lau@adelaide.edu.au

Contact person for scientific queries

Name

Dennis H. Lau

Address

Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide SA 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

dennis.lau@adelaide.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Factors affecting electrogram sensing in an insertable cardiac monitor: Insights from surface electrocardiogram mapping analysis.	2023	https://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.

Trial Review

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Documents added manually

Documents added automatically