Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aortic pulse wave velocity, carotid intima media thickness (CIMT).
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
An increased risk of cardiovascular (CV) diseases has been observed in patients with inflammatory bowel diseases (IBD). The impact of IBD drugs, such as anti-TNF, anti-integrins or anti-JAK, on the risk of CV events in IBD is remains unknown. Aortic pulse wave velocity (aPWV), a measure of aortic stiffness, and carotid intima media thickness (CIMT) are both predictors of cardiovascular events and are increased in patients with IBD. The investigators aimed to prospectively compare the CV risk, CIMT, arterial stiffness and biomarkers of endothelial dysfunction at baseline and after 3 and 12 months of anti-TNF, vedolizumab and tofacitinib.
Interventions
- Other Aortic pulse wave velocity
Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness - Other carotid intima media thickness (CIMT)
carotid intima media thickness (CIMT)
Primary outcome measures
- variation of carotid intima media thickness (CIMT) between the 3 patient groups [Time frame: at the end of month 3]
Eligibility criteria
Inclusion criteria
- Ulcerative colitis evolving for at least 6 months,
- Patient older than 18 years,
- Initiating a treatment by infliximab, adalimumab, golimumab, vedolizumab or tofacitinib,
- Written informed consent.
Exclusion criteria
- Patients with anti-hypertensive, antiplatelet or lipid-lowering drugs without stable dosage within the 3 months before the study and over the study period,
- Patients with a cardiovascular event such as myocardial infarction and stroke,
- Diabetic patient,
- Pregnant women,
- Minor
- people unable to give their consent to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT04743518 · PI2020_843_0114