Inflammatory Bowel Disease and Atherosclerosis Development

March 12, 2023 updated by: Olga Mironova, I.M. Sechenov First Moscow State Medical University
The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis

Study Overview

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Moscow, Russian Federation, 119991
        • Recruiting
        • University Hospital #1
        • Contact:
        • Principal Investigator:
          • Georgy Isaev, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Inflammatory bowel disease
  • Signed informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Ulcerative colitis
Crohn disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intima-media thickness
Time Frame: 1 year
Intima-media thickness
1 year
Pulse wave velocity
Time Frame: 1 year
Pulse wave velocity
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: 1 year
1 year
Cardiovascular mortality
Time Frame: 1 year
1 year
Hospitalisation due to cardiovascular disease
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 30, 2025

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 12, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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