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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2020-03-30', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'determine the prevelance of cardiac involvement in inflamatory bowel disease', 'timeFrame': 'Baseline', 'description': 'Assesment of cardiac involvement in inflamatory bowel disease byECG,HolterECG andEchocardiography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'Aim of the study is to determine the prevelance of subclinical cardiac involvement in patients with inflamatory bowel disease.', 'detailedDescription': '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 .\n\nThe 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 .\n\nThe 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 .\n\nThe chronic inflammatory condition found in IBD is the key element in the pathogenesis of arrhythmias.\n\nIn IBD, inflammation causes mitral and aortic valvulopathies , excess TNF-α causes the thickening and shortening of the leaflets, resulting in regurgitation .\n\nMedications 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 .\n\nCyclosporine is associated with increased risk of hypertension, arrhythmias, acute coronary syndrome, and heart failure .\n\nBiological molecules are associated with increased arrhythmogenic risks . Primary preventive measures of arterial thromboembolism include maintaining the remission, strict control of cardiovascular risk factors .\n\nThe 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.\n\nMethodology:\n\nAll Patints will be subjected to the followings :\n\nFull history taking including\n\n* Duration of illness\n* Symptoms of disease activity\n* Symptoms of extraintestinal manifestation\n* Family history of cardiac disease\n* History of traditional cardiovascular risk factors diabetes,hypertension,Dyslipidaemia,cigarette smooking)\n* Therapeutic history Examination\n* Body mass index.\n* Vital signs( pulse,blood pressure,temperature).\n* Cardiac examination.\n\nLabaratory investigations\n\n* Complete blood count - serum electrolytes\n* ESR - CRP\n* lipid profile - blood glucose level\n* TSH,T3,T4\n\nECG\n\n* Ischaemic changes\n* Any type of arrythmia\n* Prolonged QT interaval\n\nHolter ECG\n\nEchocardiography\n\n* Systolic and diastolic dysfunctions\n* Wall motion abnormalities\n* Valvular heart disease\n* Ventricular hypertrophy\n* Atrial and ventricular dimentions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'IBD patients who have no previous history of cardiac disease.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inflamatory bowel disease patients without previous history of cardiac disease.\n\nExclusion Criteria:\n\n* Patients known to have previous cardiac disease.'}, 'identificationModule': {'nctId': 'NCT04330105', 'briefTitle': 'Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease', 'orgStudyIdInfo': {'id': 'inflamatory bowel disease'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ECG, HolterECG ,Echocardiography', 'type': 'DEVICE', 'description': 'ECG, HolterECG ,Echocardiography to determine any type of arrythmia,ischaemic heart disease,valvular heart disease,systolic and diastolic dysfunction'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hossam Eldin Abdelhafez, M.B.B.Ch., M.sc.', 'role': 'CONTACT', 'email': 'hossam_essam83@yahoo.com', 'phone': '01008628429'}, {'name': 'Muhammad Hossam Eldeen Maghraby, Prof. of internal medicine', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hossam Eldin Mohammed Essam Abdelhafez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Subclinical cardiac involvement in patients with inflamatory bowel disease', 'investigatorFullName': 'Hossam Eldin Mohammed Essam Abdelhafez', 'investigatorAffiliation': 'Assiut University'}}}}