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Inflammatory Bowel Disease and Atherosclerosis Development

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05781737
Collaborator
(none)
150
Enrollment
1
Location
27
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Inflammatory Bowel Disease and Atherosclerosis Development
    Actual Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Jan 30, 2024
    Anticipated Study Completion Date :
    Jan 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Ulcerative colitis
    Crohn disease
    Control group

    Outcome Measures

    Primary Outcome Measures

    1. Intima-media thickness [1 year]

      Intima-media thickness

    2. Pulse wave velocity [1 year]

      Pulse wave velocity

    Secondary Outcome Measures

    1. All cause mortality [1 year]

    2. Cardiovascular mortality [1 year]

    3. Hospitalisation due to cardiovascular disease [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Inflammatory bowel disease

    • Signed informed consent

    Exclusion Criteria:

    • Pregnancy

    • Other conditions affecting the prognosis

    • Psychiatric disorders affecting the participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital #1 Moscow Russian Federation 119991

    Sponsors and Collaborators

    • I.M. Sechenov First Moscow State Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Olga Mironova, Professor, I.M. Sechenov First Moscow State Medical University
    ClinicalTrials.gov Identifier:
    NCT05781737
    Other Study ID Numbers:
    • 22-22
    First Posted:
    Mar 23, 2023
    Last Update Posted:
    Mar 23, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Intestinal Diseases
    Inflammatory Bowel Diseases
    Cardiovascular Diseases
    Atherosclerosis
    Inflammation

    Study Results

    No Results Posted as of Mar 23, 2023