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Trial registered on ANZCTR


Registration number
ACTRN12621001098820
Ethics application status
Approved
Date submitted
2/07/2021
Date registered
18/08/2021
Date last updated
22/07/2022
Date data sharing statement initially provided
18/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Observing Risk Factors for Heart Disease in Inflammatory Bowel Disease
Scientific title
Modulating Cardiovascular Risk in Inflammatory Bowel Disease Patients.
Secondary ID [1] 304688 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 322670 0
Cardiovascular Disease 322671 0
Irritable Bowel Syndrome 322975 0
Ulcerative Colitis 322976 0
Condition category
Condition code
Oral and Gastrointestinal 320285 320285 0 0
Crohn's disease
Cardiovascular 320286 320286 0 0
Other cardiovascular diseases
Oral and Gastrointestinal 320546 320546 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is observing the cardiovascular disease regression in patients who are at risk of cardiovascular disease and are requiring treatment for their Crohn's Disease or the Ulcerative Colitis.

All patients will be provided the standard Crohn's Disease or Ulcerative Colitis biologic therapy that is available on the pharmacutical benefits scheme (PBS) if they meet the criteria outlined by the PBS. This therapy could be either Adalimumab or Infliximab at their standard dosing regieme.

Patients will attend their regular clinic appointments, which the protocol was designed to accommodate. Clinic appointments will occur at baseline, at week 12 and at week 24. The clinic appointments will take approximately 20 to 30 minutes each. The Computer Tomography Coronary Angiogram (CCTA) scan will occur on a separate visit and will take 1 hour in total on both the baseline and week 24 visit.
Intervention code [1] 321064 0
Early Detection / Screening
Comparator / control treatment
The comparator arm of this study are patients who have the same risk factor however are considered health people (i.e. no chronic medical condition). Healthy controls will not receive any medical therapy.
Control group
Active

Outcomes
Primary outcome [1] 328138 0
The mean change in volume of non-calcified coronary atheromatous plaque (NCP) from baseline to end of intervention period (24 weeks) measured by CCTA, corrected for vessel (luminal) volume, and expressed as the percentage change over baseline in IBD patients initiating biologic therapy
Timepoint [1] 328138 0
All patients will attend a baseline appointment, an appointment at week 12 and an appointment at week 24 with the primary outcome being measured at week 24.
Primary outcome [2] 328649 0
Prevalence of high-risk plaques, assessed by Computer Tomography (CT) Coronary Angiogram, between the test cohort Inflammatory Bowel Disease (IBD) patients and the control cohort of healthy controls, matched for age, gender, and cardiovascular risk factors, at baseline.
Timepoint [2] 328649 0
All patients will attend a baseline appointment, an appointment at week 12 and an appointment at week 24 with the primary outcome being measured at week 24.
Secondary outcome [1] 397798 0
The difference in the mean change in normalised volume of noncalcified plaques (NCPs) from baseline to end of intervention period (24 weeks), measured by Coronary computed tomography angiography (CCTA) between the test and control cohorts
Timepoint [1] 397798 0
All patients will attend a baseline appointment, an appointment at week 12 and an appointment at week 24 with the secondary outcome being measured at week 24.
Secondary outcome [2] 397799 0
Inflammatory bowel disease burden assessed by measuring hs-CRP and ESR levels in a blood sample.
Timepoint [2] 397799 0
All patients will attend a baseline appointment, an appointment at week 12 and an appointment at week 24 with the secondary outcome being measured at week 24.
Secondary outcome [3] 398762 0
The difference in the mean change in the prevalence of high-risk plaques (HRPs) from baseline to end of intervention period (24 weeks), measured by Coronary computed tomography angiography (CCTA) between the test and control cohorts
Timepoint [3] 398762 0
All patients will attend a baseline appointment, an appointment at week 12 and an appointment at week 24 with the secondary outcome being measured at week 24.
Secondary outcome [4] 398763 0
Inflammatory bowel disease burden assessed by measuring faecal calprotectin levels in a stool sample.
Timepoint [4] 398763 0
All patients will attend a baseline appointment, an appointment at week 12 and an appointment at week 24 with the secondary outcome being measured at week 24.

Eligibility
Key inclusion criteria
For IBD Patients:
1. A diagnosis of Ulcerative Colitis or Crohn’s Disease that has been diagnosed as per definition criteria no sooner than 12 weeks prior to baseline, and;
a. Requires the commencement of an anti-TNFa agent.
b. And has failed no more than one prior biologic
c. Has a CDAI of 300 or Partial Mayo Score of 6, as per Medicare guidelines for re-imbursement of biologic and a Faecal Calprotectin level of greater than 250 and/or a CRP
greater than 10.
d. Is on a dose of less than 10mg of prednisolone and equivalent at baseline.
e. Is eligible by Medicare PBS criteria to commence a biologic.

For Healthy Controls:
1 People who do not have IBD or another inflammatory disease (such as rheumatoid arthritis).
2. Be over the age of 18 years

For All Patients (IBD and Healthy controls):
1. Be at least 40 years in age and have at least 1 risk factor of cardiovascular disease. Risk factors include Smoking, Hypertension, Dyslipidaemia, Obesity, Controlled Diabetes and First degree relative with ischaemic heart disease.

Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For IBD Patients:
1. Contraindication to biologic therapy, such as an active, serious infection or malignancy.
2. CDAI of less than 300 or Partial Mayo Score less than 6.
3. Fibro-stenotic disease confirmed on endoscopy or imaging.
4. Any live vaccinations prior to randomisation.
5. Concurrent use of a second biologic or small molecule (e.g., JAK inhibitor).
6. Prior failure of 2 of more biologics
7. For ulcerative colitis patients, a diagnosis of acute severe ulcerative colitis (ASUC).

For All Patients (Healthy Controls and IBD):
1. eGFR less than 30
2. Allergy to contrast dye or shellfish.
3. Presence of a serious medical condition that may preclude patient from follow- up.
4. Some diabetic medications, as these have been documented to interact adversely with the contrast provided during CCTA. These will be assessed on a case- by- case basis by the supervising Cardiologist.
5. Cardiac stents in-situ or previous coronary artery bypass graft.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
As this is a pilot study in an evidence free zone, power calculations are unlikely to be beneficial. We plan to recruit 20 patients in each of the IBD and non IBD control groups. Matching will occur at the age, gender, and number of cardiovascular risk strata. Baseline differences between the two cohorts with respect to mean NCP volume and HRP prevalence will be assessed. The mean change in the normalized NCP volume measured as a % and prevalence of HRPs, between baseline and 24 weeks, will be compared:
(i) Between the two cohorts
(ii) Between baseline and 24 weeks within the IBD cohort

Comparisons will be made using student T-test for normally distributed data and Mann-Whitney U test for non- parametric data. Logistic regression analysis for variables found to affect differences in plaque volume with a P -value difference <0.1 will be entered into the multivariate model. Backward stepwise regression analysis will be used to remove a covariate that does not meet the 0.05 p-value threshold. Variables of interest that will be ‘forced’ into the regression equation include mean change in hs-CRP and FC level, IBD duration, and mean change in CDAI score.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
15/08/2023
Actual
Sample size
Target
40
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19910 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 34609 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 309058 0
Commercial sector/Industry
Name [1] 309058 0
Celltrion Healthcare
Country [1] 309058 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Dr, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 310000 0
None
Name [1] 310000 0
Address [1] 310000 0
Country [1] 310000 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308934 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 308934 0
Ethics committee country [1] 308934 0
Australia
Date submitted for ethics approval [1] 308934 0
05/05/2021
Approval date [1] 308934 0
21/05/2021
Ethics approval number [1] 308934 0
RGS0000004706

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

Contacts
Principal investigator
Name 112386 0
Dr Lena Thin
Address 112386 0
Harry Perkins Institute of Medical Research
Fiona Stanley Hospital
11 Robin Warren Dr
MURDOCH WA 6150
Country 112386 0
Australia
Phone 112386 0
+61 861511154
Fax 112386 0
Email 112386 0
Lena.Thin@health.wa.gov.au
Contact person for public queries
Name 112387 0
Daniel Lightowler
Address 112387 0
Harry Perkins Institute of Medical Research
Fiona Stanley Hospital
11 Robin Warren Dr
MURDOCH WA 6150
Country 112387 0
Australia
Phone 112387 0
+61 861511154
Fax 112387 0
Email 112387 0
Daniel.Lightowler@uwa.edu.au
Contact person for scientific queries
Name 112388 0
Daniel Lightowler
Address 112388 0
Harry Perkins Institute of Medical Research
Fiona Stanley Hospital
11 Robin Warren Dr
MURDOCH WA 6150
Country 112388 0
Australia
Phone 112388 0
+61 861511154
Fax 112388 0
Email 112388 0
Daniel.Lightowler@uwa.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
Privacy regulations


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12401Study protocol    382332-(Uploaded-02-07-2021-19-26-33)-Study-related document.docx
12402Ethical approval    382332-(Uploaded-02-07-2021-19-26-49)-Study-related document.pdf
12403Informed consent form    382332-(Uploaded-02-07-2021-19-27-01)-Study-related document.docx



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.