ANZCTR - Registration

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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]

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)

Condition category

Condition code

Cardiovascular

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]

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]

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]

12 months post-commencement of drug/placebo

Secondary outcome [1]

Maximum AAA diameter assessed from CT images

Timepoint [1]

12 months post-commencement of drug/placebo

Secondary outcome [2]

Maximum AAA diameter assessed from ultrasound images

Timepoint [2]

12 months post-commencement of drug/placebo

Secondary outcome [3]

AAA Peak Wall Stress estimated by a single investigator using the A4research software (A4research, VASCOPS GmbH, Graz, Austria)

Timepoint [3]

12 months post-commencement of drug/placebo

Secondary outcome [4]

Serum lipids: Total cholesterol, triglycerides, LDL and HDL concentrations assessed by using automated assays (Hitachi 917, Roche Diagnostics GmBH, Mannheim, Germany)

Timepoint [4]

12 months post-commencement of drug/placebo

Secondary outcome [5]

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]

12 months post-commencement of drug/placebo

Secondary outcome [6]

Profiling of circulating RNAs using micro-arrays, next generation sequencing and real-time PCR

Timepoint [6]

12 months post-commencement of drug/placebo

Secondary outcome [7]

Health-related quality of life assessed by short form 36 (SF-36) questionnaires

Timepoint [7]

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]

The Townsville Hospital - Douglas

Recruitment hospital [2]

Mackay Base Hospital - Mackay

Recruitment hospital [3]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [4]

Gosford Private Hospital - Gosford

Recruitment postcode(s) [1]

4814 - Douglas

Recruitment postcode(s) [2]

4740 - Mackay

Recruitment postcode(s) [3]

4006 - Herston

Recruitment postcode(s) [4]

2250 - Gosford

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University Queensland Research Centre for Peripheral Vascular Disease (QRC-PVD)

Address [1]

James Cook University
1 James Cook Drive
Queensland Research Centre for Peripheral Vascular Disease
College of Medicine and Dentistry
Building 47 Room 109
Townsville, Qld, 4811

Country [1]

Australia

Primary sponsor type

University

Name

James Cook University

Address

1 James Cook Drive
Townsville, Qld, 4811

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Prince Charles Hospital HREC (EC00168)

Ethics committee address [1]

Metro North Hospital and Health Service
The Prince Charles Hospital
Building 14
Rode Road, Chermside QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2015

Approval date [1]

31/08/2015

Ethics approval number [1]

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

Prof Jonathan Golledge

Address

School of Medicine, James Cook University,
1 James Cook Drive, Douglas,
Queensland 4811

Country

Australia

Phone

+61 7 4433 1417

Fax

+61 7 4433 1401

Email

jonathan.golledge@jcu.edu.au

Contact person for public queries

Name

Jenna Pinchbeck

Address

College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811

Country

Australia

Phone

+61 7 47815449

Fax

N/A

Email

jenna.pinchbeck@jcu.edu.au

Contact person for scientific queries

Name

Jonathan Golledge

Address

College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811

Country

Australia

Phone

+61 7 4433 1417

Fax

+61 7 4433 1401

Email

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

Source	Title	Year of Publication	DOI
Embase	Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): Study protocol for a randomised controlled trial.	2017	https://dx.doi.org/10.1186/s13063-017-2304-x

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