None listed
Conditions
Brief summary
Atherosclerosis is a disease that is thought to be primarily inflammatory in origin. It is well established that patients with inflammatory diseases, including inflammatory bowel disease (IBD), are at higher risk of experiencing poor cardiovascular outcomes. Recent studies have shown having active disease seems to be the key driver for these outcomes in IBD patients. We aim to look at whether commencing treatment for IBD in patients who are at high risk of developing these poor cardiovascular outcomes reduces their risk.
Interventions
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.
Patie
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.
Sponsors
Fiona Stanley Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed