Trial Review

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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 information initially 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] 301510 0
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 317851 0
Cardiac Arrhythmia Management 318167 0
Condition category
Condition code
Cardiovascular 315900 315900 0 0
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] 317818 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324112 0
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] 324112 0
Retrospective analysis of hospital medical records between July 2017 to June 2020
Secondary outcome [1] 383787 0
Number of abnormalities detected by device check (This is a composite outcome comprised of occasions of arrhythmia, malfunction or necessary reprogramming)
Timepoint [1] 383787 0
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?
No
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)
SA
Recruitment hospital [1] 16900 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 30551 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305951 0
Self funded/Unfunded
Name [1] 305951 0
Nil.
Country [1] 305951 0
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] 306406 0
None
Name [1] 306406 0
Address [1] 306406 0
Country [1] 306406 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306194 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306194 0
Royal Adelaide Hospital
Port Road, ADELAIDE, SA 5000
Ethics committee country [1] 306194 0
Australia
Date submitted for ethics approval [1] 306194 0
13/05/2020
Approval date [1] 306194 0
19/05/2020
Ethics approval number [1] 306194 0
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 103042 0
A/Prof Dennis Lau
Address 103042 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide, South Australia 5000
Country 103042 0
Australia
Phone 103042 0
+61 8 8313 9000
Fax 103042 0
Email 103042 0
[email protected]
Contact person for public queries
Name 103043 0
A/Prof Dennis Lau
Address 103043 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide, South Australia 5000
Country 103043 0
Australia
Phone 103043 0
+61 8 8313 9000
Fax 103043 0
Email 103043 0
[email protected]
Contact person for scientific queries
Name 103044 0
A/Prof Dennis Lau
Address 103044 0
Centre for Heart Rhythm Disorders
Royal Adelaide Hospital
Cardiology 4G751-769
The University of Adelaide
Port Rd, Adelaide, South Australia 5000
Country 103044 0
Australia
Phone 103044 0
+61 8 8313 9000
Fax 103044 0
Email 103044 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo 69th CSANZ Annual Scientific Meeting 43rd Annual S... [More Details]
Conference abstractNo Heart Rhythm, Vol. 18, No. 8, August Supplement 20... [More Details]
Plain language summaryNo A total of 739 CIED checks were performed in the p... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Burden of Cardiac Implantable Electronic Device Checks in the Peri-MRI Setting: The CHECK-MRI Study.2023https://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.