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

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

Study Overview

• Status: Unknown
• Conditions: Cardiac MRI in IBD Patient
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cardiovascular affection in IBD patients	Incidence of cardiovascular affection in IBD patients	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of cardiovascular affection in IBD patients	Incidence of cardiovascular affection in IBD patients	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Khaled Mohamed, Assiut univerty

Publications and helpful links

General Publications

• Bernstein CN, Benchimol EI, Bitton A, Murthy SK, Nguyen GC, Lee K, Cooke-Lauder J, Kaplan GG. The Impact of Inflammatory Bowel Disease in Canada 2018: Extra-intestinal Diseases in IBD. J Can Assoc Gastroenterol. 2019 Feb;2(Suppl 1):S73-S80. doi: 10.1093/jcag/gwy053. Epub 2018 Nov 2.
• Matsuura E, Atzeni F, Sarzi-Puttini P, Turiel M, Lopez LR, Nurmohamed MT. Is atherosclerosis an autoimmune disease? BMC Med. 2014 Mar 18;12:47. doi: 10.1186/1741-7015-12-47.
• Fung G, Luo H, Qiu Y, Yang D, McManus B. Myocarditis. Circ Res. 2016 Feb 5;118(3):496-514. doi: 10.1161/CIRCRESAHA.115.306573.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): November 30, 2021
• Study Completion (ANTICIPATED): November 30, 2021

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases
• Other Study ID Numbers: cardiac MRI in IBD patient

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No