ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

EAGER

Linked study record

Health condition

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

Transradial Coronary Angiography

Condition category

Condition code

Cardiovascular

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]

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]

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]

At completion of the coronary angiogram.

Secondary outcome [1]

Procedure time. Collected by Cath lab radiographer who is educated on the study protocol

Timepoint [1]

By completion of coronary angiogram

Secondary outcome [2]

Time to selective coronary intubation
Collected by Cath lab radiographer who is educated on the study protocol

Timepoint [2]

By completion of coronary angiogram

Secondary outcome [3]

Crossover to alternative peripheral wire
Collected by Cath lab radiographer who is educated on the study protocol

Timepoint [3]

By completion of coronary angiogram
Collected by Cath lab radiographer who is educated on the study protocol

Secondary outcome [4]

Overall Bleeding complications – Bleeding academic research consortium (BARC) criteria
Recorded by Cath lab nursing staff who are educated in study protocol

Timepoint [4]

Assessed for up to 1 month post procedure

Secondary outcome [5]

Vascular complications – Valve academic research consortium - 2 (VARC 2) criteria

Timepoint [5]

Assessed for up to 1 month post procedure

Secondary outcome [6]

Radial spasm - Recorded by radiographer on data collection sheet as directed by technician who will make decision of spasm encountered

Timepoint [6]

Assessed continuously throughout the coronary angiogram procedure

Secondary outcome [7]

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]

Assessed for up to 1 month post procedure

Secondary outcome [8]

Time to access aorta - Recorded by radiographer in data entry form.

Timepoint [8]

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?

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]

Gosford Hospital - Gosford

Recruitment hospital [2]

John Hunter Hospital - New Lambton

Recruitment postcode(s) [1]

2250 - Gosford

Recruitment postcode(s) [2]

2305 - New Lambton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gosford Hospital & Central Coast Local Health District

Address [1]

Gosford Hospital. 75 Holden St, Gosford, NSW, 2250

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gosford Hospital CCLHD

Address

Gosford Hospital. 75 Holden St, Gosford, NSW, 2250

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Hunter New England Human Research Ethics Committee, Lookout Road, New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

27/07/2022

Ethics approval number [1]

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

Dr Tom Ford

Address

Cardiology Department, Gosford Hospital, 75 Holden St, Gosford,, NSW, 2250

Country

Australia

Phone

+614 26 267 347

Fax

tom.ford@health.nsw.gov.au

Contact person for public queries

Name

Tom Ford

Address

Cardiology Department, Gosford Hospital, 75 Holden St, Gosford,, NSW, 2250

Country

Australia

Phone

+61 02 4320 2111

Fax

brenda.campbell@health.nsw.gov.au

Contact person for scientific queries

Name

Tom Ford

Address

Cardiology Department, Gosford Hospital, 75 Holden St, Gosford,, NSW, 2250

Country

Australia

Phone

+61 02 4320 2111

Fax

brenda.campbell@health.nsw.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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17223	Study protocol					384751-(Uploaded-05-10-2022-11-04-51)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
5190	Study results article	Yes			EAGER Published article.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

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