Observing Risk Factors for Heart Disease in Inflammatory Bowel Disease

Not Applicable

Recruiting

• Conditions: Crohn's Disease; Irritable Bowel Syndrome; Cardiovascular Disease; Ulcerative Colitis; Oral and Gastrointestinal - Crohn's disease; Cardiovascular - Other cardiovascular diseases; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12621001098820
• Lead Sponsor: Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-18
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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:
1People 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.

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

• Study Type: Observational
• Study Design: Not specified