Cardiovascular Manifestation of Inflamatory Bowel Disease Patient ( Tissue Doppler Echocardiography and Cardiac MRI )

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04656015
Collaborator
(none)
100
12

Study Details

Study Description

Brief Summary

  1. Evaluation of cardiovascular changes using Doppler echocardiography and cardiac MRI in IBD patients

  2. To detect the frequency of myocardial injury in IBD patients

  3. To detect the sensitivity and specificity of echocardiography for the detection of cardiac injury in comparison to cardiac MRI in IBD patients

Condition or Disease Intervention/Treatment Phase
  • Device: MRI

Detailed Description

The burden of extra-intestinal disease is high in patients with IBD, some of whom respond to or are prevented by treating the bowel inflammation, whereas others require specific treatment because they are independent of the underlying bowel inflammation .

Cardiovascular diseases are the major causes of mortality and morbidity worldwide. They may arise for various reasons such as obesity, type 2 diabetes, genetic, environmental, dietary, and lifestyle factors. Besides all these, there is much evidence suggesting that inflammation is an important player in the pathogenesis of heart disease, as well as atherogenesis and atherosclerosis . A most common systemic inflammatory disease is inflammatory bowel disease (IBD), which is a collection of ulcerative colitis and Crohn's disease, a chronic intestinal disease that may arise due to different factors, and is precipitated by environmental and genetic susceptibility Tissue Doppler imaging (TDI) is a useful echocardiographic technique to evaluate global and regional myocardial systolic as well as diastolic function. It can also be used to quantify right ventricular and left atrial function.

To date, cardiac magnetic resonance imaging (cMRI) is mostly used to detect significantly decreased EFs and abnormalities in wall motion. Contrast enhancement (CE) CMR is a more sensitive technique of cMRI and can detect areas of myocardial damage in patients with acute myocarditis .

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Cardiovascular Manifestation of Inflamatory Bowel Disease Patient ( Tissue Doppler Echocardiography and Cardiac MRI )
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Incidence of cardiovascular affection in IBD patients [baseline]

    Incidence of cardiovascular affection in IBD patients

Secondary Outcome Measures

  1. Incidence of cardiovascular affection in IBD patients [baseline]

    Incidence of cardiovascular affection in IBD patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • IBD patients presented with disease flare, which is grouped by the 3 domains of disease severity:

  • Measurable inflammatory burden (C-reactive protein, mucosal lesions, upper gastrointestinal involvement, and disease extent.

  • Disease course (including structural damage, history/extension of intestinal resection, perianal disease, number of flares, and extraintestinal manifestations)

Exclusion Criteria:
  • Patients with poor echocardiographic window, previously diagnosed as IHD, complete heart block, mitral stenosis, prosthetic mitral valve, congenital heart disease with a left to right shunt, and CKD patients will be excluded from the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Khaled Mohamed, Assiut univerty

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mervat Sayed Kamal Sayed, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT04656015
Other Study ID Numbers:
  • cardiac MRI in IBD patient
First Posted:
Dec 7, 2020
Last Update Posted:
Dec 7, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2020