Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001209583
Ethics application status
Approved
Date submitted
3/11/2015
Date registered
6/11/2015
Date last updated
7/06/2021
Date data sharing statement initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
IMAGEN: Effect of a dietary supplement on abdominal aortic aneurysm (AAA) growth
Scientific title
Effect of a dietary supplement on abdominal aortic aneurysm (AAA) growth assessed by determining changes in AAA volume by CT imaging.
Secondary ID [1] 287776 0
None
Universal Trial Number (UTN)
U1111-1176-1198
Trial acronym
IMAGEN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm (AAA) 296667 0
Condition category
Condition code
Cardiovascular 296887 296887 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration of 2g of a dietary supplement twice daily for 12 months. Drug capsule return and control diary will monitor adherence.
Intervention code [1] 293169 0
Treatment: Drugs
Comparator / control treatment
Placebo. The placebo will be identical in taste and appearance to the dietary supplement but without the active ingredient. The frequency and duration of use will also be identical to the active drug.
Control group
Placebo

Outcomes
Primary outcome [1] 296489 0
The primary outcome measure will be AAA growth estimated by an increase in total infrarenal aortic volume on CT images. Central reading of the CT images will be performed by a single experienced observer who has previously been shown to have excellent imaging analysis reproducibility and will be blinded to the intervention allocation.
Timepoint [1] 296489 0
12 months post-commencement of drug/placebo
Secondary outcome [1] 318596 0
Maximum AAA diameter assessed from CT images



Timepoint [1] 318596 0
12 months post-commencement of drug/placebo
Secondary outcome [2] 318597 0
Maximum AAA diameter assessed from ultrasound images
Timepoint [2] 318597 0
12 months post-commencement of drug/placebo
Secondary outcome [3] 318598 0
AAA Peak Wall Stress estimated by a single investigator using the A4research software (A4research, VASCOPS GmbH, Graz, Austria)
Timepoint [3] 318598 0
12 months post-commencement of drug/placebo
Secondary outcome [4] 318602 0
Serum lipids: Total cholesterol, triglycerides, LDL and HDL concentrations assessed by using automated assays (Hitachi 917, Roche Diagnostics GmBH, Mannheim, Germany)
Timepoint [4] 318602 0
12 months post-commencement of drug/placebo
Secondary outcome [5] 318603 0
Circulating AAA biomarkers including Serum resistin, plasma IFN-gamma, plasma CCL22, plasma D-dimer, plasma MMP-2, plasma MMP-9, plasma cathepsin S, serum OPN, plasma OPG and serum SOST. Concentrations will be measured using established commercial ELISAs (R&D Systems).
Timepoint [5] 318603 0
12 months post-commencement of drug/placebo
Secondary outcome [6] 318604 0
Profiling of circulating RNAs using micro-arrays, next generation sequencing and real-time PCR
Timepoint [6] 318604 0
12 months post-commencement of drug/placebo
Secondary outcome [7] 318605 0
Health-related quality of life assessed by short form 36 (SF-36) questionnaires
Timepoint [7] 318605 0
completed at 0, 6 and 12 months of the study period

Eligibility
Key inclusion criteria
The study will include patients who provide written informed consent and have the following eligibility criteria:
- An infrarenal AAA measuring a minimal diameter of 30 mm on ultrasound or CT
- No current indication for AAA repair according to the treating physician
- High likelihood of compliance with treatment over 12 months according to the treating physician and local study coordinator
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following exclusion criteria will be used:
- Symptomatic, ruptured or infected AAAs
- Previous abdominal aortic surgery
- Current participation in another randomised trial
- The treating physician feels the patient is not suitable for trial entry

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)
Trial participants who meet the inclusion/exclusion criteria and provide Informed Consent will be allocated to either treatment- or placebo group according to a computer-generated randomisation list by contacting the holder of the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer was blocked at a 1:1 ratio and stratified by recruitment site and aortic diameter (30-34, 35-39, 40-44, 45-49, larger than 50 mm). All trial staff, investigators and participants are blinded to the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/02/2016
Actual
13/01/2016
Date of last participant enrolment
Anticipated
31/12/2018
Actual
24/02/2017
Date of last data collection
Anticipated
Actual
9/03/2018
Sample size
Target
164
Accrual to date
75
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 4558 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 4559 0
Mackay Base Hospital - Mackay
Recruitment hospital [3] 4560 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 4561 0
Gosford Private Hospital - Gosford
Recruitment postcode(s) [1] 12178 0
2250 - Gosford
Recruitment postcode(s) [2] 12177 0
4006 - Herston
Recruitment postcode(s) [3] 12176 0
4740 - Mackay
Recruitment postcode(s) [4] 12175 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 292314 0
University
Name [1] 292314 0
James Cook University Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD)
Country [1] 292314 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Townsville, Qld, 4811
Country
Australia
Secondary sponsor category [1] 290992 0
None
Name [1] 290992 0
Address [1] 290992 0
Country [1] 290992 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293786 0
The Prince Charles Hospital HREC (EC00168)
Ethics committee address [1] 293786 0
Metro North Hospital and Health Service
The Prince Charles Hospital
Building 14
Rode Road, Chermside QLD 4032
Ethics committee country [1] 293786 0
Australia
Date submitted for ethics approval [1] 293786 0
27/07/2015
Approval date [1] 293786 0
31/08/2015
Ethics approval number [1] 293786 0
HREC/15/QPCH/157

Summary
Brief summary
IMAGEN is a multicentre, prospective, parallel group, randomised, double-blinded
placebo-controlled trial to assess if 4g of a dietary supplement daily over 12 months will reduce AAA growth.
Participants who consent will undergo a thorough screening assessment for safety and suitability. Assessments include; physical and clinical examination, blood test, CT and Ultrasound of the abdomen, quality of life questionnaire and diet assessment. If the participants meet all inclusion criteria and no exclusion criteria they will be randomised (randomly allocated) to either the dietary supplement or placebo group. The participant will be blinded to the supplement name and it will be referred to as "the supplement" from the moment of initial contact. The dietary supplement and a placebo equivalent powder will be separately packaged in 500mg dose capsules. The capsules will be
dispensed by an independent and unblinded pharmacist. Participants will be instructed to have four 500mg capsules twice per day at 8am and 8pm. Participants will revisit the site centre at 6 and 12 months after starting the trial to monitor adverse events, compliance and perform assessments. Participants will be contacted by telephone at 1, 3 and 9 months to monitor compliance and adverse events.
The team will consist of experienced investigators, vascular surgeons, coordinators and researchers at each site. A steering committee, data and safety committee and publications committee will be established to oversee various aspects of the study to ensure the aims of the study are met while upholding the protocol
Trial website
http://ncre-pad.registry.org.au/clinical-studies
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61298 0
Prof Jonathan Golledge
Address 61298 0
School of Medicine, James Cook University,
1 James Cook Drive, Douglas,
Queensland 4811
Country 61298 0
Australia
Phone 61298 0
+61 7 4433 1417
Fax 61298 0
+61 7 4433 1401
Email 61298 0
jonathan.golledge@jcu.edu.au
Contact person for public queries
Name 61299 0
Ms Jenna Pinchbeck
Address 61299 0
College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811
Country 61299 0
Australia
Phone 61299 0
+61 7 47815449
Fax 61299 0
N/A
Email 61299 0
jenna.pinchbeck@jcu.edu.au
Contact person for scientific queries
Name 61300 0
Prof Jonathan Golledge
Address 61300 0
College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811
Country 61300 0
Australia
Phone 61300 0
+61 7 4433 1417
Fax 61300 0
+61 7 4433 1401
Email 61300 0
jonathan.golledge@jcu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
data will not be shared as this was not originally written in the protocol or patient informed consent form that the participant signed. Therefore we did not obtain approval or consent to provide this data.


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
SourceTitleYear of PublicationDOI
EmbaseInositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-2304-x
N.B. These documents automatically identified may not have been verified by the study sponsor.