NCT03868332

Brief Summary

Heart disease and failure are the major causes of mortality and morbidity worldwide, despite significant advances in medical technologies in the diagnosis and treatment of the disease. Cardiovascular disease may arise for various reasons including the steadily increasing incidence of obesity, type 2 diabetes, genetic, environmental, dietary and lifestyle factors. Besides all these, there is much evidence suggetsing that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Status
unknown

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

First Submitted

Initial submission to the registry

March 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

March 7, 2019

Last Update Submit

March 7, 2019

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

  • atherosclerotic effects in patients with inflammatory bowel disease

    hypertension and ischemic heart disease

    two years duration

Study Arms (2)

inflammatory bowel diease patients

normal indivuals

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

population of the study will be classified into two groups, one with inflammatory bowel disease ,other is healthy volunteers. both groups will be investigated for early cardiovascular atherosclerotic changes.

You may qualify if:

  • Patients who are diagnosed as ulcerative colitis / Crhon s disease however in activity or in remission attending the the outpatient clinics and inpatient of gastroenterology units of Internal medicine department

You may not qualify if:

  • Previous history of hypertension , diabetes mellitus, Dyslipidemia
  • Previous history of cardiovascular or cerebrovascular events
  • Autoimmune , Neoplastic diseases
  • Thromboembolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Hussien Ahmed EL-Amen, MD

    Assiut University

    STUDY CHAIR

Central Study Contacts

Hussien Ahmed EL-Amen, MD

CONTACT

0201004084187drmaam2007@gmail.com

Soheir Mustafa Kassem, MD

CONTACT

01069347314soheir1980@gmail.com

Study Design

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

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 11, 2019

Study Start

July 20, 2019

Primary Completion

March 20, 2021

Study Completion

March 20, 2021

Last Updated

March 11, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share