NCT05781737

Brief Summary

The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

January 16, 2023

Last Update Submit

October 3, 2024

Conditions

Inflammatory Bowel DiseasesCardiovascular DiseasesInflammationArterial Stiffness

Outcome Measures

Primary Outcomes (2)

  • Intima-media thickness

    Intima-media thickness

    1 year

  • Pulse wave velocity

    Pulse wave velocity

    1 year

Secondary Outcomes (3)

  • All cause mortality

    1 year

  • Cardiovascular mortality

    1 year

  • Hospitalisation due to cardiovascular disease

    1 year

Study Arms (3)

Ulcerative colitis

Crohn disease

Control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients with ulcerative colitis, 50 patients with Crohn disease, 50 patients without inflammatory bowel disease

You may qualify if:

  • Inflammatory bowel disease
  • Signed informed consent

You may not qualify if:

  • Pregnancy
  • Other conditions affecting the prognosis
  • Psychiatric disorders affecting the participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital #1

Moscow, 119991, Russia

Location

Related Links

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2023

First Posted

March 23, 2023

Study Start

November 1, 2022

Primary Completion

January 30, 2024

Study Completion

January 30, 2025

Last Updated

October 4, 2024

Record last verified: 2024-10

Locations

RU(1)