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

ACTRN12620000866909

Ethics application status

Approved

Date submitted

12/06/2020

Date registered

31/08/2020

Date last updated

25/11/2021

Date data sharing statement initially provided

31/08/2020

Date results provided

25/11/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessing the clinical burden of Cardiac Implantable Electronic Device checks in the Peri-Magnetic Resonance Image scan setting which are performed to assess implant function and allow necessary device reprogramming.

Scientific title

Assessing the clinical burden of Cardiac Implantable Electronic Device checks in the Peri-Magnetic Resonance Image scan setting – CHECK-MRI study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

CHECK-MRI study

Linked study record

Health condition

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

Cardiac arrhythmia devices

Cardiac Arrhythmia Management

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

No intervention/exposure. This is a retrospective analysis of all Cardiac Implanted Electronic Device (CIED) checks for Magnetic Resonance Image (MRI) scans performed at the Royal Adelaide Hospital over a 3 year period from July 1st 2017 through until June 30th 2020. This analysis will assess the clinical burden and characteristics of these checks. Data collection will include;
Device and leads parameters (make and model, date of implant, device battery status, lead sensing, impedance, threshold results).
Patient rhythm status.
Patient demographics (age, gender).
MRI conditions (scan type, region, sequence, orientation).
Date and time of MRI scan and CIED check.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Burden of device checks (This is a composite outcome comprised of number of checks, occasion of service, and duration between pre-scan and post-scan device programming).

Timepoint [1]

Retrospective analysis of hospital medical records between July 2017 to June 2020

Secondary outcome [1]

Number of abnormalities detected by device check (This is a composite outcome comprised of occasions of arrhythmia, malfunction or necessary reprogramming)

Timepoint [1]

Retrospective analysis of hospital medical records between July 2017 to June 2020

Eligibility

Key inclusion criteria

Cardiac Implanted Electronic Device insitu and had an Magnetic Resonance Image scan performed at Royal Adelaide Hospital

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

None

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

All data will be analyzed retrospectively. The nominal data will be presented as number of events (n) and percentage (%). Normally distributed continuous data will be expressed as mean ± standard deviation. The difference between groups will be analyzed using chi-squared comparisons for the nominal data and the normal continuous data tested with unpaired t-tests between groups. Clinical predictors of abnormalities identified by device check issues will be evaluated.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

11/09/2020

Actual

11/09/2020

Date of last participant enrolment

Anticipated

11/09/2021

Actual

11/09/2021

Date of last data collection

Anticipated

11/09/2021

Actual

11/09/2021

Sample size

Target

200

Accrual to date

Final

295

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]

Nil.

Address [1]

Nil.

Country [1]

Primary sponsor type

Individual

Name

A/Prof Dennis Lau

Address

Centre for Heart Rhythm Disorders
Cardiology Department
Royal Adelaide Hospital
Port Road, Adelaide, SA. 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

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]

Royal Adelaide Hospital
Port Road, ADELAIDE, SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/05/2020

Approval date [1]

19/05/2020

Ethics approval number [1]

13213

Summary

Brief summary

Patients with a Cardiac Implantable Electronic Device (CIED) can undergo Magnetic Resonance Imaging (MRI) scan provided that certain device conditions are met. This requires interrogation of the device and fulfillment of conditionality checklists in the peri-MRI setting. The number of patients with a CIED is increasing and many of whom may at some stage require an MRI, it is therefore anticipated that the number of requests for CIED check in the peri-MRI setting will increase. Additionally, recent data suggests that non-conditional CIED are safe for MRI scan, and if permitted by our radiology department would further increase the burden of peri-MRI scan CIED checks.  Our proposed research is to analyze the clinical burden and model of care for CIED checks in the peri-MRI setting

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Dennis Lau

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

dennis.lau@sa.gov.au

Contact person for public queries

Name

Dennis Lau

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

dennis.lau@sa.gov.au

Contact person for scientific queries

Name

Dennis Lau

Address

Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 8313 9000

Fax

dennis.lau@sa.gov.au

Data sharing statement

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

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

Source	Title	Year of Publication	DOI
Embase	The Burden of Cardiac Implantable Electronic Device Checks in the Peri-MRI Setting: The CHECK-MRI Study.	2023	https://dx.doi.org/10.1016/j.hlc.2022.10.005

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