- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05781737
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
Status
Recruiting
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
- Name: Georgy Isaev, MD
- Phone Number: +79854894120
- Email: isago1804@gmail.com
Study Locations
-
-
-
Moscow, Russian Federation, 119991
- Recruiting
- University Hospital #1
-
Contact:
- Georgy Isaev, MD
- Phone Number: +79854894120
- Email: isago1804@gmail.com
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-22
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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