Clinical trial NCT04330105: Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease
Official title: Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients who have no previous history of cardiac disease.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients known to have previous cardiac disease.

Primary outcomes:
measure: determine the prevelance of cardiac involvement in inflamatory bowel disease
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: