Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04330105
Status:
UNKNOWN
Last Update Posted:
2020-04-03
First Post:
2020-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease
Sponsor:
Hossam Eldin Mohammed Essam Abdelhafez
Organization:
Study Overview
Official Title:
Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: