Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease

April 1, 2020 updated by: Hossam Eldin Mohammed Essam Abdelhafez
Aim of the study is to determine the prevelance of subclinical cardiac involvement in patients with inflamatory bowel disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular manifestations in patients with IBD mostly occur as immune-related consequences and include the following: pericarditis, myocarditis, venous and arterial thromboembolism, left ventricle impairment, arrhythmias and conduction disorders and valvulopathy .

The prevalence of classical cardiovascular risk factors is relatively lower in IBD patients than in the general population . However, the risk of coronary heart disease is higher in IBD patients .

The pathophysiology of cardiac involvement may be Systemic inflammation for prolonged periods that can cause platelet aggregation and endothelial dysfunction leading to the development of atherosclerosis and CVD .

The chronic inflammatory condition found in IBD is the key element in the pathogenesis of arrhythmias.

In IBD, inflammation causes mitral and aortic valvulopathies , excess TNF-α causes the thickening and shortening of the leaflets, resulting in regurgitation .

Medications of IBD may be involved in pathogenesis of cardiac involvement as follows 5-ASA and its derivatives can cause myopericarditis . Atrial fibrillation and prolonged QT interval may occur during azathioprine use .

Cyclosporine is associated with increased risk of hypertension, arrhythmias, acute coronary syndrome, and heart failure .

Biological molecules are associated with increased arrhythmogenic risks . Primary preventive measures of arterial thromboembolism include maintaining the remission, strict control of cardiovascular risk factors .

The diagnostic modalities to find out cardiac involvement include; The 12-lead electrocardiogram . Transthoracic echocardiography which represent the method of choice to evaluate both systolic and diastolic functions of Lt ventricle.

Methodology:

All Patints will be subjected to the followings :

Full history taking including

  • Duration of illness
  • Symptoms of disease activity
  • Symptoms of extraintestinal manifestation
  • Family history of cardiac disease
  • History of traditional cardiovascular risk factors diabetes,hypertension,Dyslipidaemia,cigarette smooking)
  • Therapeutic history Examination
  • Body mass index.
  • Vital signs( pulse,blood pressure,temperature).
  • Cardiac examination.

Labaratory investigations

  • Complete blood count - serum electrolytes
  • ESR - CRP
  • lipid profile - blood glucose level
  • TSH,T3,T4

ECG

  • Ischaemic changes
  • Any type of arrythmia
  • Prolonged QT interaval

Holter ECG

Echocardiography

  • Systolic and diastolic dysfunctions
  • Wall motion abnormalities
  • Valvular heart disease
  • Ventricular hypertrophy
  • Atrial and ventricular dimentions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

IBD patients who have no previous history of cardiac disease.

Description

Inclusion Criteria:

  • Inflamatory bowel disease patients without previous history of cardiac disease.

Exclusion Criteria:

  • Patients known to have previous cardiac disease.

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the prevelance of cardiac involvement in inflamatory bowel disease
Time Frame: Baseline
Assesment of cardiac involvement in inflamatory bowel disease byECG,HolterECG andEchocardiography
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hossam Eldin Mohammed Essam Abdelhafez

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 (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

July 30, 2022

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • inflamatory bowel disease

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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