Inflammatory Bowel DiseasesNCT05781737
Inflammatory Bowel Disease and Atherosclerosis Development
An observational study of Inflammatory Bowel Diseases and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Cardiovascular Diseases, Inflammation
- How many people
- 115 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2022to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with ulcerative colitis, 50 patients with Crohn disease, 50 patients without inflammatory bowel disease
Who may be able to join
- Inflammatory bowel disease
- Signed informed consent
Who cannot join
- Pregnancy
- Other conditions affecting the prognosis
- Psychiatric disorders affecting the participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis
- Medical subject headings
- Inflammatory Bowel Diseases, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis | Not described | |
| Crohn disease | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima-media thickness
Intima-media thickness
Measured: 1 year
Pulse wave velocity
Pulse wave velocity
Measured: 1 year
Secondary outcomes (3)
All cause mortality
Measured: 1 year
Cardiovascular mortality
Measured: 1 year
Hospitalisation due to cardiovascular disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Nov 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Trushina, I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781737
- Sponsor's protocol ID
- 22-22
- Status last verified
- May 2026
- First submitted
- 16 Jan 2023
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Bowel Disease and Atherosclerosis Development
- ClinicalTrials.gov ID
- NCT05781737
- Acronym / sponsor ID
- 22-22
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis | – | – |
| Crohn disease | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with ulcerative colitis, 50 patients with Crohn disease, 50 patients without inflammatory bowel disease
Key inclusion criteria (2 listed)
- Inflammatory bowel disease
- Signed informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Other conditions affecting the prognosis
- Psychiatric disorders affecting the participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intima-media thickness
Time frame: 1 year
Intima-media thickness
Pulse wave velocity
Time frame: 1 year
Pulse wave velocity
3 secondary outcomes
All cause mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 1 year
Hospitalisation due to cardiovascular disease
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Isaikina M.A., Isaev G.O., Pyatigorets E.S., Yurazh M.A., Mironova O.I. Ulcerative colitis and cardiovascular disease. Case report. Systemic Hypertension. 2022;19(4):53-57. (In Russ.)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Cardiovascular Diseases, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intima-media thickness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.