NCT06695065

Brief Summary

Value of speckle tracking echocardiography in early assessment of cardiac function in inflammatory bowel disease .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Oct 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Oct 2025Dec 2027

First Submitted

Initial submission to the registry

November 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

October 2, 2025

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 14, 2024

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Subclincal cardiovascular events in IBD patients.

    Assessment the predictive ability of Speckle TRACKING Echocardiograpy in development of subclinical cardiovascular events in IBD patients.

    through study completion, an average of 2 year

  • Relation between isease activity and cardiac function

    Evaluation of the relationship between disease activity and cardiac function as measured by Speckle tracking Echocardiograpy.

    through study completion, an average of 2 year

Secondary Outcomes (1)

  • correlation of Speckle TRACKING Echocardiograpy findings with traditional echocardiographic parameters

    through study completion, an average of 1 year

Study Arms (2)

Study group adult with ulcerative colitis

50 Adult patients with ulcerative colitis

control group

50 age and sex matched control group.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

History: Demographic data; age, sex. History of the disease: onset, duration, medication. Family history of disease. History of comorbidities: hypertension, diabetes, ischemic heart diseases. Laboratory investigations: Fasting blood glucose, 2 hr postprandial and glycated haemoglobin A1c (HbA1c). Lipid profile: LDL, HDL, triglyceride, cholesterol. Inflammatory markers: CRP, ESR Complete blood picture Evaluation of Disease Severity Partial Mayo score consists three of the four components of the standard Mayo score, excluding endoscopic findings (stool frequency, rectal bleeding and physician's global assessment). Each component is assigned a score of 0-3, and total score ranges from 0 to 9 for each patient. -Echocardiographic Examination

You may qualify if:

  • Age (18-60) yrs.
  • Both sexes.
  • Patients with IBD either in active form or in remission.

You may not qualify if:

  • Patients with ischemic heart disease. -Patients with other comorbidities affecting heart as uncontrolled hypertension or diabetes. -
  • Pregnant females.
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Asmaa Abdelshafy Mohamed

CONTACT

Noor el_deen Abdelazeem Mohamed

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 19, 2024

Study Start

October 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 2, 2025

Record last verified: 2024-11