Inflammatory Bowel Disease and Atherosclerosis Development | NCT05781737

Studies
Inflammatory Bowel Disease and Atherosclerosis Development

NCT05781737

Sponsor

I.M. Sechenov First Moscow State Medical University

Status

Completed

Last Update Posted

May 12, 2026Actual

Enrollment

115Actual

Phase

Not provided

Conditions

Inflammatory Bowel Diseases
Cardiovascular Diseases
Inflammation
Arterial Stiffness

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Jan 30, 2024Actual

Completion Date

Jan 30, 2025Actual

First Submitted Date

Jan 16, 2023

First Submission Date that Met QC Criteria

Mar 12, 2023

First Posted Date

Mar 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olga Trushina, Professor, I.M. Sechenov First Moscow State Medical UniversityPrincipal Investigator

Lead Sponsor

I.M. Sechenov First Moscow State Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inflammatory bowel disease
Signed informed consent

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital #1		Moscow		119991	Russia

References Module

Citations

Not provided

Label	Type	Description	Intervention Names
Ulcerative colitis
Crohn disease
Control group

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D015212	Inflammatory Bowel Diseases
D002318	Cardiovascular Diseases
D007249	Inflammation