Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease

Aim of the study is to determine the prevelance of subclinical cardiac involvement in patients with inflamatory bowel disease.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Device: ECG, HolterECG ,Echocardiography

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

Participation Criteria

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

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	Assesment of cardiac involvement in inflamatory bowel disease byECG,HolterECG andEchocardiography	Baseline

Collaborators and Investigators

• Sponsor: Hossam Eldin Mohammed Essam Abdelhafez

Study record dates

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: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• 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