Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000641897
Ethics application status
Approved
Date submitted
13/06/2012
Date registered
18/06/2012
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Date results information initially provided
20/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an ECG criteria tool to assist clinicians in the accurate interpretation of electrocardiograms (ECGs) of ‘young’ athletes - a randomised controlled trial
Scientific title
Evaluation of the ability of sports-medicine clinicians to accurately interpret a young athlete electrocardiogram with the assistance of a criteria tool versus their ability to evaluate the electrocardiogram using normal practise, in order to decide which electrocardiograms require further evaluation
Secondary ID [1] 280660 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Cardiac Death 286680 0
Condition category
Condition code
Cardiovascular 286983 286983 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The provision to clinicians of an electrocardiogram (ECG) interpretation criteria tool. This is a tool created by a team of clinician / researchers based on guidelines created by the European Society of Cardiology. It is used to provide clinicians with clarifications of ECG 'abnormalities' that may in fact be normal variants for an athlete. Assessment using the tool should take 2 to 2.5 hours (for assessment of 40 ECGs). This assessment is undertaken only once, with the other group performing the assessment without the tool (i.e. following usual practice).
Intervention code [1] 285069 0
Diagnosis / Prognosis
Intervention code [2] 285072 0
Early detection / Screening
Comparator / control treatment
Usual practice of the clinician for ECG interpretation
Control group
Active

Outcomes
Primary outcome [1] 287320 0
The primary outcome will be number of correctly interpreted ECGs compared with a gold standard interpretation in each group. The gold standard is determined by a world leader in sports cardiology who has assessed the ECGs (using his clinical expertise and the European Society of Cardiology guidelines) to determine which ECGs would see the athlete require further investigation.
Timepoint [1] 287320 0
After batch of ECGs completed
Secondary outcome [1] 297898 0
One secondary outcome will be sensitivity of the tool-assisted interpretations compared with usual practice
Timepoint [1] 297898 0
After batch of ECGs completed
Secondary outcome [2] 297911 0
One secondary outcome will be specificity of the tool-assisted interpretations compared with usual practice
Timepoint [2] 297911 0
After batch of ECGs completed

Eligibility
Key inclusion criteria
Clinicians who have are involved in the care of young athletes and interpretation of their pre-particpation screening ECGs
General Practitioners
Sports Physicians
Sports Medicine Registrars
Cardiologists
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cardiologists who have a special interest in sports cardiology

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinicians are asked to complete the intepretation of the an inital batch of ECGs and are then randmonised to treatment or control by a clinician not aware of the results of the first batch of ECGs.

Allocation concealment is performed in that once a subject is deemed eligible for inclusion by one investigator, that information is passed to another investigator who assigns the subject a study ID. This latter individual holds an allocation schedule which then determines which Study IDs should receive the intervention and which should be the controls. The initial investigator is therefore not aware at the time that a subject is deemed eligible for inclusion as to which group they will be assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of a random sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2012
Actual
7/06/2012
Date of last participant enrolment
Anticipated
Actual
25/03/2013
Date of last data collection
Anticipated
Actual
5/08/2013
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 4359 0
New Zealand
State/province [1] 4359 0

Funding & Sponsors
Funding source category [1] 285427 0
Other Collaborative groups
Name [1] 285427 0
Sports Medicine New Zealand (Auckland Branch)
Country [1] 285427 0
New Zealand
Primary sponsor type
Individual
Name
Dr Daniel Exeter
Address
Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
Vic 3004
Australia
Country
Australia
Secondary sponsor category [1] 284280 0
Individual
Name [1] 284280 0
Assoc Prof Raina Elley
Address [1] 284280 0
Dept General Practice & Primary Health Care
School of Population Health
University of Auckland
Private Bag 92 019
Auckland 1142
Country [1] 284280 0
New Zealand
Secondary sponsor category [2] 284281 0
Individual
Name [2] 284281 0
Dr Mark Fulcher
Address [2] 284281 0
Dept General Practice & Primary Health Care
School of Population Health
University of Auckland
Private Bag 92 019
Auckland 1142
Country [2] 284281 0
New Zealand
Other collaborator category [1] 276861 0
Individual
Name [1] 276861 0
Dr Jonathan Drezner
Address [1] 276861 0
Department of Family Medicine
University of Washington, Box 354410
Seattle, WA 98195
Country [1] 276861 0
United States of America
Other collaborator category [2] 276862 0
Individual
Name [2] 276862 0
Dr Irfan Asif
Address [2] 276862 0
UT Graduate School of Medicine
UT Medical Center
1924 Alcoa Highway
Knoxville, Tennessee 37920
Country [2] 276862 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287438 0
UNIVERSITY OF AUCKLAND HUMAN PARTICIPANTS ETHICS COMMITTEE
Ethics committee address [1] 287438 0
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Ethics committee country [1] 287438 0
New Zealand
Date submitted for ethics approval [1] 287438 0
06/10/2011
Approval date [1] 287438 0
22/11/2011
Ethics approval number [1] 287438 0
2011 / 7733

Summary
Brief summary
This study aims to document sensitivity and specificity when the ECGs of young athletes are interpreted by clinicians (excluding sports cardiologists) compared with interpretation by expert sports cardiologists. It also aims to assess the effectiveness of the ECG criteria tool in improving this sensitivity and specificity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34303 0
Dr Daniel Exeter
Address 34303 0
Axis Sports Medicine Specialists
212 Wairau Road
Wairau Valley
Auckland 0627
New Zealand
Country 34303 0
New Zealand
Phone 34303 0
+6495219811
Fax 34303 0
Email 34303 0
[email protected]
Contact person for public queries
Name 17550 0
Dr Dr Daniel Exeter
Address 17550 0
Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
VIC 3004
Country 17550 0
Australia
Phone 17550 0
+61 3 9420 4300
Fax 17550 0
Email 17550 0
[email protected]
Contact person for scientific queries
Name 8478 0
Dr Dr Daniel Exeter
Address 8478 0
Olympic Park Sports Medicine Centre
Olympic Boulevard
Melbourne
VIC 3004
Country 8478 0
Australia
Phone 8478 0
+61 3 9420 4300
Fax 8478 0
Email 8478 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
Some of the collated data will be available on request


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4091Statistical analysis plan  [email protected]
4092Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Exeter DJ, Elley CR, Fulcher ML, et al Standardise... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStandardised criteria improve accuracy of ECG interpretation in competitive athletes: a randomised controlled trial.2014https://dx.doi.org/10.1136/bjsports-2013-093360
N.B. These documents automatically identified may not have been verified by the study sponsor.