Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Anti-TNF, Vedolizumab and Tofacitinib on Aortic Stiffness, Carotid Intima-media Thickness and Cardiovascular Risk of Patients With Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Aortic pulse wave velocity
* Other: carotid intima media thickness (CIMT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: anti-TNF<br> | Other: Aortic pulse wave velocity<br>* Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness<br>Other: carotid intima media thickness (CIMT)<br>* carotid intima media thickness (CIMT)<br>|
| Active Comparator: vedolizumab<br> | Other: Aortic pulse wave velocity<br>* Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness<br>Other: carotid intima media thickness (CIMT)<br>* carotid intima media thickness (CIMT)<br>|
| Active Comparator: tofacitinib<br> | Other: Aortic pulse wave velocity<br>* Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness<br>Other: carotid intima media thickness (CIMT)<br>* carotid intima media thickness (CIMT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of carotid intima media thickness (CIMT) between the 3 patient groups |  | at the end of month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis, cardiovascular risk, CIMT