Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000043730
Ethics application status
Approved
Date submitted
1/12/2021
Date registered
17/01/2022
Date last updated
2/08/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of subcutaneous glyceryl trinitrate on radial artery diameter and the utility in radial access coronary angiography
Scientific title
The effect of subcutaneous glyceryl trinitrate on radial artery diameter and the utility in radial access coronary angiography
Secondary ID [1] 305926 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 324517 0
Coronary angiography 324518 0
Transradial artery access 324519 0
Condition category
Condition code
Cardiovascular 321989 321989 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a subcutaneous injection of glyceryl trinitrate (GTN) prior to radial artery puncture as part of a coronary angiogram. One millilitre (1ml) GTN (500 micrograms / millilitre) with 1ml lidocaine 2% will be used once only. This injection will be provided by the blinded operator performing the procedure.
Intervention code [1] 322317 0
Treatment: Drugs
Comparator / control treatment
The control will be a subcutaneous injection of normal saline 0.9% (placebo) as part of the usual administration of local anaesthetic (2% lidocaine).
Control group
Placebo

Outcomes
Primary outcome [1] 329774 0
Radial artery diameter measured using ultrasound at site of subcutaneous injection
Timepoint [1] 329774 0
Measurement of radial artery pre-injection and 1 minute post injection measured using a stopwatch
Primary outcome [2] 329775 0
Time from first puncture to successful arterial sheath insertion measured using a stopwatch
Timepoint [2] 329775 0
At the time of successful arterial sheath insertion
Primary outcome [3] 329951 0
Radial artery diameter measured using ultrasound at opposite site to that of subcutaneous injection
Timepoint [3] 329951 0
Measurement of radial artery pre-injection and 1 minute post injection measured using a stopwatch
Secondary outcome [1] 403723 0
Total number of forward passes of the needle during radial artery puncture as assessed by operator self-report
Timepoint [1] 403723 0
At the time of successful arterial sheath insertion
Secondary outcome [2] 403724 0
Participant satisfaction as assessed by a pain score with a Visual Analogue Scale (VAS)
Timepoint [2] 403724 0
Assessed post completion of coronary angiogram
Secondary outcome [3] 404397 0
Rate of conversion to transfemoral access for completion of coronary angiogram as reported by the operator and documented in the procedure report
Timepoint [3] 404397 0
At the time of successful completion of coronary angiogram
Secondary outcome [4] 404398 0
Incidence of adverse affects associated with the use of subcutaneous glyceryl trinitrate (GTN) as reported in the patient medical record
Timepoint [4] 404398 0
At the time of completion of coronary angiogram

Eligibility
Key inclusion criteria
Patient attending for a planned coronary angiogram – outpatient or inpatient
Planned for transradial approach
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presentation requiring emergent coronary angiography including ST-elevation myocardial infarction (STEMI)
Cardiogenic shock
Requiring inotropic support or intra-aortic balloon pump insertion
Known severe aortic stenosis
Known left ventricular outflow tract obstruction (including hypertrophic cardiomyopathy)
No transthoracic echocardiogram in the month prior to procedure
Systolic blood pressure <90mmHg at the time of the procedure
Previous intolerance or reaction to glyceryl trinitrate
Known history of glaucoma or stroke or significant head trauma
Phosphodiesterase inhibitor (e.g. Sildenafil / Tadalafil) use in the preceding 4 days
Have been on regular long-acting nitrates in the previous 48 hours

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)
Allocation via a 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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be completed using Excel and SPSS 23 software. Experimental precision has been estimated based on previous research projects. As the study progresses, retrospective experimental precision analyses will be performed to guide estimated sample sizes. There will be a paired analysis on the data to assess for statistical significance. Student’s t test will be used to compare continuous data. Univariate and multivariate regression analysis will be used to examine potential correlations between radial artery diameter and variables such as sex, age, height, body mass index (BMI), hypertension, diabetes, stroke, chronic kidney disease and peripheral vascular disease. All statistical analyses will be carried out for 5% level of significance and a two-tailed p value of <0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
1/08/2022
Date of last participant enrolment
Anticipated
1/10/2022
Actual
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
300
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22900 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 38207 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 310269 0
Hospital
Name [1] 310269 0
Royal Brisbane & Women's Hospital
Country [1] 310269 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Butterfield Street
Herston, QLD
4029
Country
Australia
Secondary sponsor category [1] 311411 0
None
Name [1] 311411 0
Address [1] 311411 0
Country [1] 311411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309940 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 309940 0
Ethics committee country [1] 309940 0
Australia
Date submitted for ethics approval [1] 309940 0
13/09/2021
Approval date [1] 309940 0
23/11/2021
Ethics approval number [1] 309940 0
HREC/2021/QRBW/79305

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

Contacts
Principal investigator
Name 115918 0
Dr Alexander Binnie
Address 115918 0
Department of Cardiology
Level 3, James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston, QLD
4029
Country 115918 0
Australia
Phone 115918 0
+610419887874
Fax 115918 0
Email 115918 0
[email protected]
Contact person for public queries
Name 115919 0
Alexander Binnie
Address 115919 0
Department of Cardiology
Level 3, James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston, QLD
4029
Country 115919 0
Australia
Phone 115919 0
+610419887874
Fax 115919 0
Email 115919 0
[email protected]
Contact person for scientific queries
Name 115920 0
Alexander Binnie
Address 115920 0
Department of Cardiology
Level 3, James Mayne Building
Royal Brisbane & Women's Hospital
Butterfield Street
Herston, QLD
4029
Country 115920 0
Australia
Phone 115920 0
+610419887874
Fax 115920 0
Email 115920 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14308Study protocol    383215-(Uploaded-19-12-2021-23-46-02)-Study-related document.pdf



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.