Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000377831
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
1/04/2021
Date last updated
16/03/2023
Date data sharing statement initially provided
1/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Fish oil supplementation on inflammation of blood vessels in people with heart disease
Scientific title
Effect of high-dose fish oil supplementation on arterial inflammation in patients with elevated lipoprotein (a)
Secondary ID [1] 303514 0
03016 - SCGOPHCG
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease (CVD) 320835 0
arterial inflammation 320836 0
Condition category
Condition code
Cardiovascular 318661 318661 0 0
Coronary heart disease
Inflammatory and Immune System 319036 319036 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fish oils are a rich source of long-chain omega-3 fatty acids, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Fish oil taken as oral capsules (1g/capsule), containing omega-3 marine triglycerides 600mg as: EPA 360mg and DHA 240mg, taken as 6 capsules per day (3.6g omega-3 per day) for 12 weeks.
Patients adherence is measured by consumed capsule counts routinely.
Intervention code [1] 319797 0
Prevention
Intervention code [2] 319798 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326605 0
Changes in arterial inflammation using 18F-FDG-PET/CT imaging.
Timepoint [1] 326605 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [1] 392095 0
Lp(a), determined before and after 12-week intervention by a routine immunoassay (Quantia assay, Abbott Diagnostics) with fasting serum.
Timepoint [1] 392095 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [2] 393196 0
Total cholesterol, determined before and after 12-week intervention by standard enzymatic methods with fasting serum.
Timepoint [2] 393196 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [3] 393197 0
LDL-cholesterol, determined before and after 12-week intervention by standard enzymatic methods with fasting serum.
Timepoint [3] 393197 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [4] 393198 0
triglycerides, determined before and after 12-week intervention by standard enzymatic methods with fasting serum.
Timepoint [4] 393198 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [5] 393199 0
high-density lipoprotein cholesterol, determined before and after 12-week intervention by standard enzymatic methods with fasting serum.
Timepoint [5] 393199 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [6] 393200 0
high-sensitivity C-reactive protein (hs-CRP), determined before and after 12-week intervention by ELISA (enzyme-linked immunosorbent assay) with fasting serum.
Timepoint [6] 393200 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [7] 393201 0
interleukin 6 (IL-6), determined before and after 12-week intervention by ELISA (enzyme-linked immunosorbent assay) with fasting serum.
Timepoint [7] 393201 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [8] 393202 0
interleukin 1-b (IL-1b), determined before and after 12-week intervention by ELISA (enzyme-linked immunosorbent assay) with fasting serum.
Timepoint [8] 393202 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [9] 393203 0
tumor necrosis factor-a (TNF-a), determined before and after 12-week intervention by ELISA (enzyme-linked immunosorbent assay) with fasting serum.
Timepoint [9] 393203 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [10] 393205 0
pentraxin 3, determined before and after 12-week intervention by ELISA (enzyme-linked immunosorbent assay) with fasting serum.
Timepoint [10] 393205 0
Baseline and 12 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
Inclusion criteria: aged between 45-69 years of age with elevated fasting Lp(a) levels (>0.5g/L), stable coronary artery disease and on maximally tolerated doses of lipid-lowering therapy, including a statin, and achieving a fasting LDL-cholesterol of <4.0 mmol/L. Stable coronary artery disease will be defined as previous coronary event (myocardial infarction, stroke, re-vascularisation procedure) >3 months ago or established coronary artery calification (>400) following CT coronary angiogram.
Minimum age
45 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: unstable coronary artery disease or a cardiovascular event within the last 3 months, fasting blood sugar level >7.2 mmol/L, tachyarrhthmias, women who are pregnant or lactating, a previous diagnosis of a severe co-existing medical condition that would prevent participation (eg: severe dementia or terminal illness), <45 or >70 years of age, or unable to provide a written informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome is a reduction in arterial inflammation. This will be assessed using a paired t-test assessing change in maximal target to background ratio of carotid arteries and aorta. All analysis will be performed at the completion of the trial on an intention to treat basis. Participants who withdraw from the study will be replaced.

This is a pilot proof-of-concept study designed to identify if high-dose fish oil supplementation can provide additional benefit to high-risk patients who are already on maximally tolerated lipid-lowering therapy. We anticipate a difference in TBRmax of 30%, with 15 participants providing 80% power to test the null hypothesis, with an a-error of 5%.

All hardcopy data will be stored in individual Case Report Forms (CRFs), which will be stored in a locked filing cabinet in the office of the study coordinator at the Medical School, UWA, Level 4 MRF Building, Rear 50 Murray Street, Perth. All electronic data will be re-identified with a unique ID code and stored on a password protected computer that is regularly backed up. Stored biological samples will be re-identified with a unique study ID and stored in -80 freezer in the Medical School, UWA, Level 4 MRF Building, Rear 50 Murray Street, Perth. All records will be retained for 15 years after the completion of the trial, after which they will be securely destroyed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/12/2019
Date of last participant enrolment
Anticipated
10/08/2022
Actual
11/07/2022
Date of last data collection
Anticipated
8/12/2022
Actual
12/01/2023
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18774 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 33220 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 307926 0
Charities/Societies/Foundations
Name [1] 307926 0
Royal Perth Hospital Medical Research Foundation
Country [1] 307926 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
School of Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Level 4, Rear of 50 Murray Street, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 308655 0
None
Name [1] 308655 0
Address [1] 308655 0
Country [1] 308655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307926 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 307926 0
Ethics committee country [1] 307926 0
Australia
Date submitted for ethics approval [1] 307926 0
08/02/2018
Approval date [1] 307926 0
30/05/2019
Ethics approval number [1] 307926 0
RGS0000003016

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

Contacts
Principal investigator
Name 108950 0
Prof Gerald Watts
Address 108950 0
School of Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Medical Research Foundation Building, Level 4, Rear of 50 Murray Street, Perth WA 6000
Country 108950 0
Australia
Phone 108950 0
+61 0892240248
Fax 108950 0
+61 0892240246
Email 108950 0
[email protected]
Contact person for public queries
Name 108951 0
Gerald Watts
Address 108951 0
School of Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Medical Research Foundation Building, Level 4, Rear of 50 Murray Street, Perth WA 6000
Country 108951 0
Australia
Phone 108951 0
+61 0892240248
Fax 108951 0
+61 0892240246
Email 108951 0
[email protected]
Contact person for scientific queries
Name 108952 0
Gerald Watts
Address 108952 0
School of Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Medical Research Foundation Building, Level 4, Rear of 50 Murray Street, Perth WA 6000
Country 108952 0
Australia
Phone 108952 0
+61 0892240248
Fax 108952 0
+61 0892240246
Email 108952 0
[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?
Individual participant data underlying published results only, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Approvals by Principal Investigator (Prof Gerald Watts, [email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10764Study protocol    381473-(Uploaded-22-02-2021-19-23-14)-Study-related document.pdf
10765Ethical approval    381473-(Uploaded-19-02-2021-19-16-36)-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
SourceTitleYear of PublicationDOI
EmbaseImproved arterial inflammation with high dose omega-3 fatty acids in patients with elevated lipoprotein(a): Selective effect of eicosapentaenoic acid?.2023https://dx.doi.org/10.1016/j.jacl.2023.08.004
N.B. These documents automatically identified may not have been verified by the study sponsor.