Inflammatory Bowel DiseasesNCT04330105
Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Hossam Eldin Mohammed Essam Abdelhafez.
Trial summary
Aim of the study is to determine the prevelance of subclinical cardiac involvement in patients with inflamatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- ECG, HolterECG ,Echocardiography
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: IBD patients who have no previous history of cardiac disease.
Who may be able to join
- Inflamatory bowel disease patients without previous history of cardiac disease.
Who cannot join
- Patients known to have previous cardiac disease.
Trial locations and contacts
No sites are listed yet.
Muhammad Hossam Eldeen Maghraby, Prof. of internal medicine contact
About this study
Aim of the study is to determine the prevelance of subclinical cardiac involvement in patients with inflamatory bowel disease.
Read the 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
- Being tested
- ECG, HolterECG ,Echocardiography
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG, HolterECG ,EchocardiographyDevice
ECG, HolterECG ,Echocardiography to determine any type of arrythmia,ischaemic heart disease,valvular heart disease,systolic and diastolic dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the prevelance of cardiac involvement in inflamatory bowel disease
Assesment of cardiac involvement in inflamatory bowel disease byECG,HolterECG andEchocardiography
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hossam Eldin Mohammed Essam Abdelhafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hossam Eldin Mohammed Essam Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330105
- Sponsor's protocol ID
- inflamatory bowel disease
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04330105
- Acronym / sponsor ID
- inflamatory bowel disease
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hossam Eldin Mohammed Essam AbdelhafezUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- IBD patients who have no previous history of cardiac disease.
Key inclusion criteria (1 listed)
- Inflamatory bowel disease patients without previous history of cardiac disease.
Key exclusion criteria (1 listed)
- Patients known to have previous cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG, HolterECG ,EchocardiographyECG, HolterECG ,Echocardiography to determine any type of arrythmia,ischaemic heart disease,valvular heart disease,systolic and diastolic dysfunction | Device | – |
Primary outcome
determine the prevelance of cardiac involvement in inflamatory bowel disease
Time frame: Baseline
Assesment of cardiac involvement in inflamatory bowel disease byECG,HolterECG andEchocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Hossam Eldeen Maghraby, Prof. of internal medicine contact
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Hossam Eldin Mohammed Essam Abdelhafez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hossam Eldin Abdelhafez, M.B.B.Ch., M.sc. (01008628429, hossam_essam83@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the prevelance of cardiac involvement in inflamatory bowel disease (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.