Modulating Cardiovascular Risk in Inflammatory Bowel Disease Patients.

Fiona Stanley Hospital0 个研究点目标入组 40 人开始时间: 2021年8月18日最近更新: 2022年8月9日

适应症

试验速览

暂无简介。

•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.

•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.

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