Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001557729
Ethics application status
Approved
Date submitted
7/10/2022
Date registered
16/12/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
16/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing Guidewire Efficacy for transradial access: The EAGER Randomised Controlled Trial
Scientific title
Enhancing guidewire efficacy for adults undergoing transradial coronary angiography: The EAGER Randomised Controlled Trial
Secondary ID [1] 308083 0
Nil known
Universal Trial Number (UTN)
Trial acronym
EAGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transradial Coronary Angiography 327773 0
Condition category
Condition code
Cardiovascular 324843 324843 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transradial coronary angiogram involves passing a catheter and guidewire through an initially inserted radial artery sheath to traverse up arterial system eventually into the aortic root. The guidewire is passed first being less traumatic than a catheter as to not cause vessel damage, then a catheter is railroaded over the guidewire to gain entry to the aorta. Completion of the angiogram involves mobilising the catheters into coronary arteries and injecting contrast which can be captured under fluoroscopic imaging. If results determine percutaneous intervention (stenting) needs to occur, catheters can be exchanged at this time and the procedure can take place. Coronary angiograms can take anywhere from 15 minutes to a few hours depending on what intervention needs to take place.

Once the radial sheath is inserted, traversing a guidewire and catheter to the aortic root can take as little as 10 to 20 seconds if a patient has favourable anatomy by the performing Cardiology Advanced Trainee or Cardiologist. If arterial tortuosity, stenosis or significant spasm are present, this can lead to difficulty or even inability to pass wires and catheters to the aorta. This can increase the duration of the procedure, predispose to arterial trauma, increase the amount of contrast needed or result in the need for alternate arterial access increasing risk of procedural complications.

Multiple guidewires exist which aid in the initial mobilisation of the angiogram catheter to the aorta. The traditionally wire was initially designed for femoral angiograms using larger arteries. Now that transradial is best practice method for coronary angiograms, alternate smaller and hydrophilic wires have been designed with suggestion they may help traverse the transradial arterial anatomy. We seek to determine if a hydrophilic J tipped 1.5mm 0.035” peripheral access wire (‘Baby J’ Glidewire, Terumo systems, Japan) is more successful that the larger traditionally used standard 3mm J tipped 0.035 guidewire in gaining access to the aorta to enable successful coronary angiogram. The procedure is observed by the radiographer do document procedure success and is verbally confirmed between the radiographer and Interventionalist at the completion of the procedure.
Intervention code [1] 324532 0
Treatment: Devices
Comparator / control treatment
The comparator group included those undergoing transradial coronary angiography using a peripheral 0.035” fixed core PTFE J-tipped guidewire upfront. This wire has been used for many years as it was initially designed to be used for femoral coronary angiography which passes through a larger arterial system than transradial, but continues in use today for radial procedures.
Control group
Active

Outcomes
Primary outcome [1] 332655 0
The primary endpoint is technical success - we define this as successful wire passage into aortic root without crossover to alternate guidewire or access site. This will be recorded by the Cath lab radiographer or angiogram procedurals on a data entry sheet who will be trained in study protocol.
Timepoint [1] 332655 0
At completion of the coronary angiogram.
Secondary outcome [1] 414264 0
Procedure time. Collected by Cath lab radiographer who is educated on the study protocol
Timepoint [1] 414264 0
By completion of coronary angiogram
Secondary outcome [2] 414265 0
Time to selective coronary intubation
Collected by Cath lab radiographer who is educated on the study protocol
Timepoint [2] 414265 0
By completion of coronary angiogram
Secondary outcome [3] 414266 0
Crossover to alternative peripheral wire
Collected by Cath lab radiographer who is educated on the study protocol
Timepoint [3] 414266 0
By completion of coronary angiogram
Collected by Cath lab radiographer who is educated on the study protocol
Secondary outcome [4] 414268 0
Overall Bleeding complications – Bleeding academic research consortium (BARC) criteria
Recorded by Cath lab nursing staff who are educated in study protocol
Timepoint [4] 414268 0
Assessed for up to 1 month post procedure
Secondary outcome [5] 414269 0
Vascular complications – Valve academic research consortium - 2 (VARC 2) criteria
Timepoint [5] 414269 0
Assessed for up to 1 month post procedure
Secondary outcome [6] 414271 0
Radial spasm - Recorded by radiographer on data collection sheet as directed by technician who will make decision of spasm encountered
Timepoint [6] 414271 0
Assessed continuously throughout the coronary angiogram procedure
Secondary outcome [7] 414272 0
Puncture Site bleeding complications (haematoma) formation - Collected in data entry sheet by Cath lab nursing staff on the day of angiography, or noted in the 4 week electronic medical record review by the study doctor.
Timepoint [7] 414272 0
Assessed for up to 1 month post procedure
Secondary outcome [8] 416672 0
Time to access aorta - Recorded by radiographer in data entry form.
Timepoint [8] 416672 0
By completion of coronary angiogram

Eligibility
Key inclusion criteria
1) Age greater than or equal to 18 years old
2) Undergoing planned best practice transradial coronary angiography at Gosford District Hospital
3) Expected to have transradial access to coronary angiography prior to the procedure
4) Radial sheath able to be inserted for transradial access
5) Provide written informed consent before study participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Obligatory femoral access
2) Previous ipsilateral forearm radial artery occlusion.
3) Emergency/salvage coronary angiography where consent cannot be obtained.
4) Enrolment in an alternate study that competes or interferes with this study.
5) Any other condition which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
6) Inability to provide informed consent for themselves.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of percentage of technical success between the groups with two-tailed pearson chi square for the primary outcome. We will also calculate odds ratio and 95%CI.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/10/2022
Date of last participant enrolment
Anticipated
10/10/2023
Actual
Date of last data collection
Anticipated
10/11/2023
Actual
Sample size
Target
310
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23273 0
Gosford Hospital - Gosford
Recruitment hospital [2] 23699 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 38642 0
2250 - Gosford
Recruitment postcode(s) [2] 39134 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 312336 0
Hospital
Name [1] 312336 0
Gosford Hospital & Central Coast Local Health District
Country [1] 312336 0
Australia
Primary sponsor type
Hospital
Name
Gosford Hospital CCLHD
Address
Gosford Hospital. 75 Holden St, Gosford, NSW, 2250
Country
Australia
Secondary sponsor category [1] 313900 0
None
Name [1] 313900 0
Nil
Address [1] 313900 0
Nil
Country [1] 313900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311704 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311704 0
Hunter New England Human Research Ethics Committee, Lookout Road, New Lambton NSW 2305
Ethics committee country [1] 311704 0
Australia
Date submitted for ethics approval [1] 311704 0
Approval date [1] 311704 0
27/07/2022
Ethics approval number [1] 311704 0

Summary
Brief summary
Rationale: Transradial access for coronary angiogram is now standard for coronary angiography. It requires a guidewire to be directed up the radial artery to the aortic root to allow safe mobilization of catheters over it into the aorta to complete the procedure. The traditional guidewire made for femoral angiograms and predating transradial angiography is the peripheral 0.035” fixed core PTFE J-tipped wire (FC0.035) with a 3mm J tip curve radius. Radial arteries are smaller than femoral arteries and typically range from 2.2mm in diameter in women, to 2.7mm in men, both smaller than the J tip curve radius of 3mm in the FC0.035 wire which may predispose to radial spasm or vessel trauma. The hydrophilic J tip ‘baby J’ guidewire with a 1.5mm J tip radius has been designed to traverse areas of radial tortuosity and stenosis easier aiming for less spasm to improve success of passing catheters to the aortic root and is commonly used in coronary angiographic suites second line. However, the FC0.035 wire is still the traditional wire used in transradial coronary angiography, and direct comparison of their procedural success has not been studies to date. If indeed the baby J wire was demonstrated to have a higher success rate in gaining access to the aortic root compared to the FC0.035 wire, it would lead to less wire changes, and less need for alternate arterial punctures and subsequent predisposition to further vascular complications. If this were the case it would suggest it the baby J wire should be considered for use first line in transradial coronary angiography.
The objective of this study is to determine if use of the baby J guidewire in transradial coronary angiogram has any difference in technical success compared to the traditionally used FC0.035” wire.
The study design is a prospective randomised controlled trial with intention to treat analysis.
The study population consists of Participants undergoing best practice coronary angiography or percutaneous intervention at Gosford District Hospital who consent to become enrolled in the trial. At least three hundred and ten Participants are aimed to be enrolled over 12 months.
The main study endpoints include the primary outcome of technical success rates between guidewires. Secondary outcomes include crossover to alternative peripheral wire, crossover to alternative access site, bleeding rates (BARC criteria), vascular complications (VARC 2 criteria), radial spasm, haematoma formation (EASY criteria) time to wire entry of subclavian, aorta, and selective coronary intubation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122062 0
Dr Tom Ford
Address 122062 0
Cardiology Department, Gosford Hospital, 75 Holden St, Gosford,, NSW, 2250
Country 122062 0
Australia
Phone 122062 0
+614 26 267 347
Fax 122062 0
Email 122062 0
tom.ford@health.nsw.gov.au
Contact person for public queries
Name 122063 0
Dr Tom Ford
Address 122063 0
Cardiology Department, Gosford Hospital, 75 Holden St, Gosford,, NSW, 2250
Country 122063 0
Australia
Phone 122063 0
+61 02 4320 2111
Fax 122063 0
Email 122063 0
brenda.campbell@health.nsw.gov.au
Contact person for scientific queries
Name 122064 0
Dr Tom Ford
Address 122064 0
Cardiology Department, Gosford Hospital, 75 Holden St, Gosford,, NSW, 2250
Country 122064 0
Australia
Phone 122064 0
+61 02 4320 2111
Fax 122064 0
Email 122064 0
brenda.campbell@health.nsw.gov.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17223Study protocol    384751-(Uploaded-05-10-2022-11-04-51)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.