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Trial registered on ANZCTR


Registration number
ACTRN12619000532101
Ethics application status
Approved
Date submitted
1/04/2019
Date registered
3/04/2019
Date last updated
12/03/2020
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Efficacy of Intravenous Magnesium in the Management of Atrial Fibrillation with a Rapid Ventricular Rate in the Emergency Department
Scientific title
The Utility of Magnesium in the Management of Atrial fibrillation with Rapid ventricular Response: A Randomised Controlled Trial (MagMAR study)
Secondary ID [1] 297600 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MagMAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 311997 0
Condition category
Condition code
Cardiovascular 310564 310564 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following randomisation, there shall be two groups as detailed below.

1. Intervention Arm – Shall receive a single intravenous administration of 20mmol of Magnesium Sulfate in 100mls of normal 0.9% saline over 30 minutes.

2. Placebo Arm – Shall receive a single intravenous administration of 100mls of 0.9% normal saline over 30 minutes.

The above interventions shall not be personalised, this is a randomised controlled study design trial and patients will all be required to sign a patient information and consent form detailing participant involvement, risks and study objectives.
Intervention code [1] 313930 0
Treatment: Drugs
Comparator / control treatment
Placebo – Shall receive a single intravenous administration of 100mls of 0.9% normal saline over 30 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 319418 0
Primary Outcome - Proportion of participants with a reduction of ventricular rate to <100 beats per minute or greater than 20% from initial heart rate at presentation. Note the primary timepoint shall be 1 hour post initiation of intervention/placebo.

It is worth noting our secondary outcomes and their associated timepoints.

Instrument to measure the primary outcome – Heart rate data shall be collected by the following;

(a) Departmental electrocardiogram every 30minutes for the first hour following commencement of the intervention then hourly thereafter (b) Telemetry (c) Routine nursing observations, at least hourly whilst in the Emergency Department


Timepoint [1] 319418 0
Primary Timepoint – 1 hours following initiation of intervention
Secondary outcome [1] 368082 0
1. Reversion on ECG/telemetry to sinus rhythm from atrial fibrillation

Timepoint [1] 368082 0
This update is of secondary timepoint section only, which previously read 'Data shall be recorded on heart rate and rhythm at 30, 60, 90, and 120 minutes, and 4 hour mark.
The UPDATE is that our team (prior to first enrolment) decided to utilise telemetry to assess HR over a 4 hour period,
So, updated time points for Heart Rate data are EVERY 10 MINUTES from time zero (ie when infusion started) to 240 minutes (4 hours)

Secondary outcome [2] 368083 0
2. Time elapsed from commencement of intervention to target (primary outcome) rate reduction
Timepoint [2] 368083 0
Assessed up to 4 hours post-intervention (more specifically at 30, 60, 90, 120 and 240 minutes) by means of above methods (ECG serial, telemetry data retrospective analysis from stored date.
Secondary outcome [3] 368084 0
3. Number of and dose of any further (besides magnesium sulfate, our intervention) of rate and/or rhythm control agents required to achieve target rate reduction.

This shall be assessed by using the hospitals widely used EMR (Electronic Medical Record) and recorded on the confidential and anonymous RedCaps data collection software.
Timepoint [3] 368084 0
Assessed up to 4 hours post-intervention and will include a review of medications used during initial admission period to gain rate or rhythm control.
Secondary outcome [4] 368085 0
4. Length of stay in the emergency department

This shall be assessed by using the hospitals widely used EMR (Electronic Medical Record) and recorded on the confidential and anonymous RedCaps data collection software.
Timepoint [4] 368085 0
At hospital discharge, and through review of the electronic medical record for admission length.
Secondary outcome [5] 368086 0
5. Need for admission to hospital ward

This shall be assessed by using the hospitals widely used EMR (Electronic Medical Record) and recorded on the confidential and anonymous RedCaps data collection software.
Timepoint [5] 368086 0
At hospital discharge, and through review of the electronic medical record to ascertain if there was an admission to any in-patient ward.
Secondary outcome [6] 368087 0
6. Re-hospitalisation at 30 days
Timepoint [6] 368087 0
30 days following intervention

Assessed via electronic medical record EMR
Secondary outcome [7] 368978 0
7. Mortality at 30 days
Timepoint [7] 368978 0
Assessed via electronic medical record EMR

Measured at 30 days following intervention

Eligibility
Key inclusion criteria
1. Greater than or equal to 18 years of age
2. ECG at presentation to Emergency Department greater than or equal to a ventricular rate of 120
3. Presenting complaint attributable to atrial fibrillation
4. Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Haemodynamically instability, in this study, defined as Systolic Blood Pressure less than 90mmHg
2. Suspected acute myocardial infarction
3. Overt sepsis suspected by treating clinician
4. Known renal impairment (egfr <30)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double blinded randomised control trial - A hospital pharmacist shall kindly make up 200 (our sample size aim) bags of 100ls normal 0.9% saline, half (100 bags) of which will also contain the intervention of 20mmol Magnesium Sulfate. These bags will be labelled 1-200 and thus treating clinicians and patients will be blinded to whether the bag contains the intervention or placebo.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple numerical randomisation whereby pharmacy makes up 100 bags containing the intervention and 100 bags containing the active control before numbering them all 1-200. A bag (randomly chosen) by the treating team at time of recruitment shall be taken and administered and that bags number recorded for eventual analysis by a researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be collated using RedCaps. Analysis will be undertaken on an intention-to-treat analysis. All binary outcomes such as hospital admission, conversion to sinus rhythm and mortality at 30 days will be analysed using a chi-squared test with results reported as relative risk with a 95% confidence interval. To compare the heart rate at set time points between the placebo and control groups a Student’s t-test will be used.

Sample size aim is 200, with 100 in each group (intervention vs active control). Note every year approximately 750 patients present to Box Hill Hospital emergency department for the treatment AF with rapid ventricular response. We assume the standard alpha and power at 0.05 and 0.80 respectively.

For our power calculation, we used standard online calculator assuming the following - Anticipated difference between groups - 15%, power 0.8, alpha 0.05, beta 0.2, resulting in sample size 200.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2019
Actual
3/04/2019
Date of last participant enrolment
Anticipated
1/12/2020
Actual
Date of last data collection
Anticipated
2/01/2021
Actual
Sample size
Target
200
Accrual to date
104
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13366 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 16112 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 25965 0
3128 - Box Hill
Recruitment postcode(s) [2] 25966 0
3128 - Box Hill Central
Recruitment postcode(s) [3] 29630 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 302146 0
Charities/Societies/Foundations
Name [1] 302146 0
Eastern Health Foundation
Country [1] 302146 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Eastern Health Foundation
Address
Box Hill Hospital
Building B, Ground Floor
8 Arnold St, Box Hill
Victoria 3128
Australia
Country
Australia
Secondary sponsor category [1] 301982 0
None
Name [1] 301982 0
Address [1] 301982 0
Country [1] 301982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302825 0
the Eastern Health Human Research Ethics Committee
Ethics committee address [1] 302825 0
Ethics committee country [1] 302825 0
Australia
Date submitted for ethics approval [1] 302825 0
12/03/2019
Approval date [1] 302825 0
01/04/2019
Ethics approval number [1] 302825 0
LR19/018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91526 0
A/Prof Andrew Teh
Address 91526 0
Department of Cardiology, Box Hill Hospital, Eastern Health, 8 Arnold Street, Box Hill, Melbourne, Victoria 3128 Australia
Country 91526 0
Australia
Phone 91526 0
+61 398953391
Fax 91526 0
Email 91526 0
[email protected]
Contact person for public queries
Name 91527 0
Louise Roberts
Address 91527 0
Department of Cardiology, Box Hill Hospital, Eastern Health, 8 Arnold Street, Box Hill, Melbourne, Victoria 3128 Australia
Country 91527 0
Australia
Phone 91527 0
+61 1300 342 255
Fax 91527 0
Email 91527 0
[email protected]
Contact person for scientific queries
Name 91528 0
Andrew Teh
Address 91528 0
Department of Cardiology, Box Hill Hospital, Eastern Health, 8 Arnold Street, Box Hill, Melbourne, Victoria 3128 Australia
Country 91528 0
Australia
Phone 91528 0
+61 398953391
Fax 91528 0
Email 91528 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
The investigator team have no plans for individuals data to be shared publically, this was not included in the study participant information and consent information leaflet.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.