Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease

NCT ID: NCT04330105

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-07-30

Brief Summary

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

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

Conditions

Inflammatory Bowel Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

ECG, HolterECG ,Echocardiography

ECG, HolterECG ,Echocardiography to determine any type of arrythmia,ischaemic heart disease,valvular heart disease,systolic and diastolic dysfunction

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients known to have previous cardiac disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hossam Eldin Mohammed Essam Abdelhafez

OTHER

Sponsor Role: lead

Responsible Party

Hossam Eldin Mohammed Essam Abdelhafez

Subclinical cardiac involvement in patients with inflamatory bowel disease

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hossam Eldin Abdelhafez, M.B.B.Ch., M.sc.

Role: CONTACT

hossam_essam83@yahoo.com

01008628429

Muhammad Hossam Eldeen Maghraby, Prof. of internal medicine

Role: CONTACT

Other Identifiers

inflamatory bowel disease

Identifier Type: -

Identifier Source: org_study_id