- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06695065
Value of Speckle Tracking Echocardiography Inflammatory Bowel Disease Patients
Value of Speckle Tracking Echocardiography in Early Assessment of Cardiac Function in Inflammatory Bowel Disease Patients
Study Overview
Status
Detailed Description
Ulcerative colitis (UC) is a common form of inflammatory bowel disease (IBD) that consists of chronic inflammatory disorders of the colon and the small intestine with unknown etiology. Chronic inflammation is the basis of complicated pathogenesis, and the course of the disease is often complicated by an immune response. Malnutrition, malabsorption and the involvement of organs other than those of the gastrointestinal tract are frequent consequences of the disease . Although extra-intestinal manifestations of IBD are common (ranging from 6% to 47%), cardiac involvement is rare.
Inflammatory bowel disease (IBD) is a known risk factor for cardiovascular disease (CVD). IBD patients have a two- to threefold increased risk of venous thromboembolism, particularly during acute flares when disrupted homeostasis of anti- and procoagulants leads to a hypofibrinolytic state. Cardiovascular manifestations in Crohn's disease (CD) and ulcerative colitis (UC) include conditions such as Takayasu's arteritis, pericarditis, and myocarditis. Chronic inflammation and altered lipid metabolism, along with long-term use of anti-inflammatory drugs (e.g., corticosteroids, TNF-α inhibitors), are thought to drive CV pathology in IBD. Additionally, chronic inflammation is linked to pathological collagen deposition in affected organs.
Although conventional echocardiography is a widely accessible and easy tool to detect cardiac abnormalities, novel echocardiographic techniques and indices offer easy, reproducible and quantitative information for evaluating left ventricle function and subclinical changes . Speckle tracking echocardiography (STE) is an advanced echocardiographic methodology for the quantification of myocardial function. STE has been successfully used to identify early subclinical cardiac involvement in a variety of asymptomatic populations with chronic diseases and unremarkable conventional echocardiography. Unlike earlier echocardiography techniques, two-dimensional speckle tracking echocardiography (2DSTE) is less angle-dependent. In addition, STE is not affected by the rotation of the heart and allows heart functions to be examined segment by segment from various echocardiographic views . Despite, studies have examined subclinical cardiac impairment in patients with IBD, to the best of our knowledge, none have explored the impact of ulcerative colitis activity on cardiac function through using STE.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Asmaa Abdelshafy Mohamed
- Phone Number: 0109950131
- Email: Asma.shafy@aun.edu.eg
Study Contact Backup
- Name: Noor el_deen Abdelazeem Mohamed
- Phone Number: 0100503518
- Email: noorelhefny@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
History:
Demographic data; age, sex. History of the disease: onset, duration, medication. Family history of disease. History of comorbidities: hypertension, diabetes, ischemic heart diseases.
Laboratory investigations:
Fasting blood glucose, 2 hr postprandial and glycated haemoglobin A1c (HbA1c). Lipid profile: LDL, HDL, triglyceride, cholesterol. Inflammatory markers: CRP, ESR Complete blood picture Evaluation of Disease Severity Partial Mayo score consists three of the four components of the standard Mayo score, excluding endoscopic findings (stool frequency, rectal bleeding and physician's global assessment). Each component is assigned a score of 0-3, and total score ranges from 0 to 9 for each patient.
-Echocardiographic Examination
Description
Inclusion Criteria:
- Age (18-60) yrs.
- Both sexes.
- Patients with IBD either in active form or in remission.
Exclusion Criteria:
- Patients with ischemic heart disease. -Patients with other comorbidities affecting heart as uncontrolled hypertension or diabetes. -
- Pregnant females.
- Malignancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Study group adult with ulcerative colitis
50 Adult patients with ulcerative colitis
|
|
control group
50 age and sex matched control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subclincal cardiovascular events in IBD patients.
Time Frame: through study completion, an average of 2 year
|
Assessment the predictive ability of Speckle TRACKING Echocardiograpy in development of subclinical cardiovascular events in IBD patients.
|
through study completion, an average of 2 year
|
|
Relation between isease activity and cardiac function
Time Frame: through study completion, an average of 2 year
|
Evaluation of the relationship between disease activity and cardiac function as measured by Speckle tracking Echocardiograpy.
|
through study completion, an average of 2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlation of Speckle TRACKING Echocardiograpy findings with traditional echocardiographic parameters
Time Frame: through study completion, an average of 1 year
|
Detection of correlation of Speckle TRACKING Echocardiograpy findings with traditional echocardiographic parameters and inflammatory markers.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Echocardiogray in IBD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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