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Trial registered on ANZCTR

Registration number

ACTRN12622001455752

Ethics application status

Approved

Date submitted

29/10/2022

Date registered

14/11/2022

Date last updated

3/04/2024

Date data sharing statement initially provided

14/11/2022

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparing fasting to no fasting before catheterisation laboratory procedures.

Scientific title

Safety and Care OF no Fasting prior to catheter laboratory procedures in Adults: a non-inferiority randomised control trial (SCOFF Trial)

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

SCOFF

Linked study record

Health condition

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

Catheterisation Procedures

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Other cardiovascular diseases

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

No fasting requirements of solids or liquids.
Patients in the interventional group are allowed to eat and drink as they please.
Patients will be questioned as to the last time of food and drink intake prior to the procedure.

This will be for pacemaker and defibrillator procedures as well as diagnostic and interventional cardiac angiography procedures.

Structural heart disease interventions, requirement for calcium modification therapy, electrophysiology studies and cardiac resynchronisation therapy procedures will be excluded

Intervention code [1]

Treatment: Other

Comparator / control treatment

Solid food fasting for 6 hours prior to catheterisation laboratory procedure.
Clear liquid fasting for 2 hours prior to catheterisation laboratory procedure.

Patients will be questioned about last food and drink intake.

Control group

Active

Outcomes

Primary outcome [1]

Composite primary endpoint of procedure related aspiration, hypotension, hyperglycaemia and hypoglycaemia.

Blood pressure measured by invasive catheterisation when available or non-invasive sphygmomanometer.
Blood sugar level (BSL) will be checked with a finger prick sample.
Aspiration pneumonia will be determined by clinician assessment in combination with chest radiography.

Timepoint [1]

Follow-up until hospital discharge.

Secondary outcome [1]

Mortality

Timepoint [1]

30 days post procedure

Secondary outcome [2]

Readmission collected via national stroke and readmission database.

Timepoint [2]

30 days post procedure

Secondary outcome [3]

Procedure related non-invasive ventilation (NIV) requirement.
Clinician assessment at the time of the procedure and review of medical records

Timepoint [3]

Until discharge

Secondary outcome [4]

Procedure related Intubation requirement based on clinician review and review of medical records.

Timepoint [4]

Until discharge

Secondary outcome [5]

Procedure related Acute Kidney Injury
Review of serology results on medical records.

Timepoint [5]

72 hours post procedure

Secondary outcome [6]

Patient reported satisfaction utilising the Popovich Preoperative Fasting Questionnaire.

Timepoint [6]

Immediately post procedure

Secondary outcome [7]

Health-related quality of life assessed using the EQ5D

Timepoint [7]

Immediately post procedure

Secondary outcome [8]

New ICU admission based on clinician review and electronic medical records.

Timepoint [8]

Immediately post procedure

Eligibility

Key inclusion criteria

• Aged over 18 years of age.
• Are referred for catheterisation laboratory procedures including coronary angiography, percutaneous coronary intervention and device implantation or replacement (pacemakers and defibrillators).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Pregnant or breastfeeding females.
• Inability to provide informed consent.
• Requirement for a general anaesthetic.
• Complex catheterisation laboratory interventions
o Chronic total occlusion, rotational atherectomy, shockwave lithotripsy or planned mechanical support (IABP/Impella)
o Balloon aortic valvuloplasty, transcatheter aortic valve implantation, mitral valve clipping
o Electrophysiologic studies – diagnostic and ablation
o Biventricular Cardiac Resynchronisation Therapy

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)

Open label. Allocation is not concealed. Blinded endpoint adjudication committee.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Prospective, randomised, open label, blinded endpoint (PROBE) design

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

5/10/2022

Date of last participant enrolment

Anticipated

3/02/2024

Actual

14/09/2023

Date of last data collection

Anticipated

31/05/2024

Actual

23/10/2023

Sample size

Target

700

Accrual to date

Final

716

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital - New Lambton

Recruitment hospital [2]

Tamworth Rural Referral Hospital - Tamworth

Recruitment hospital [3]

Gosford Hospital - Gosford

Recruitment hospital [4]

Belmont Hospital - Belmont

Recruitment hospital [5]

The Maitland Hospital - Maitland

Recruitment hospital [6]

Calvary Mater Newcastle - Waratah

Recruitment postcode(s) [1]

2305 - New Lambton

Recruitment postcode(s) [2]

2340 - Tamworth

Recruitment postcode(s) [3]

2250 - Gosford

Recruitment postcode(s) [4]

2280 - Belmont

Recruitment postcode(s) [5]

2320 - Maitland

Recruitment postcode(s) [6]

2298 - Waratah

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

John Hunter Hospital

Address [1]

Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305.

Country [1]

Australia

Primary sponsor type

Hospital

Name

John Hunter Hospital

Address

Lookout Road, New Lambton Heights New South Wales 2305

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Research Ethics Committee

Ethics committee address [1]

Level 3, Pod, HMRI, Lot 1, Kookaburra Circuit, New Lambton Heights NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/03/2022

Approval date [1]

30/08/2022

Ethics approval number [1]

Summary

Brief summary

Fasting is standard of care prior to catheter laboratory procedures. The purpose of this is to reduce the risk of aspiration events during procedural sedation. Generally, this involves 6 hours of solid food fasting with 2 hours of clear fluid fasting. 

Currently there are limited prospective data reviewing the utility of fasting versus no fasting prior to catheterisation procedures. Recently the CHOW NOW study based in America performed a randomised control trial assessing this question. They demonstrated non-inferiority of no-fasting with a pre-specified margin of 5.9%. We wish to assess the non-inferiority of no fasting for catheterisation laboratory procedures in a multicentre trial with a narrower non-inferiority margin of 3%. 

Fasting prior to procedures may be associated with patient discomfort and distress. In addition, there are some populations where oral intake is important to prevent adverse events. Examples include those with chronic kidney disease where dehydration, potentially precipitated by fasting, associates with increased risk of contrast induced nephropathy.  Moreover, patients are frequently cancelled due to lack of fasting. Relinquishing prerequisites for fasting prior to procedures may assist in providing expedited patient care and reduce adverse events related to underlying disease. 

The main risk associated with no fasting is that of aspiration pneumonia. In the CHOW NOW study, only 0.7% of the non-fasting group experienced this adverse event. This is an uncommon and treatable complication. Risks of fasting (dehydration, hypotension, hypoglycaemia, contrast induced nephropathy, patient discomfort) may outweigh the benefits in preventing the uncommon event of aspiration pneumonia. 
Though a randomised trial has already been performed, the American Society of Anaesthesiologists has requested more data prior to the acceptance of no fasting before simple catheterisation laboratory procedures.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Ferreira

Address

Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights New South Wales 2305

Country

Australia

Phone

+61 02 4921 4200

Fax

[email protected]

Contact person for public queries

Name

David Ferreira

Address

Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights New South Wales 2305

Country

Australia

Phone

+61 02 4921 4200

Fax

[email protected]

Contact person for scientific queries

Name

David Ferreira

Address

Cardiovascular Department, John Hunter Hospital, Lookout Road, New Lambton Heights New South Wales 2305

Country

Australia

Phone

+61 02 4921 4200

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

De-identified patient data will be shared in entirety. This will include demographic data, serology results, primary and secondary outcomes, patient satisfaction and quality of life results as well as 30-day follow-up.

When will data be available (start and end dates)?

Available starting immediately post-trial cessation and ending 5 years post-trial cessation

Available to whom?

Reputable researchers with sound proposals.

Available for what types of analyses?

Any proposals deemed suitable by the steering committee.

How or where can data be obtained?

Contacting the PI: [email protected]

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial)	2023	https://doi.org/10.1093/ehjopen/oead111

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically