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NCT Number: NCT04743518

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic pulse wave velocity

Other

Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness

carotid intima media thickness (CIMT)

Other

carotid intima media thickness (CIMT)

Primary outcomes

  1. variation of carotid intima media thickness (CIMT) between the 3 patient groups

    Time frame: at the end of month 3

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: VASC-UC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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