Clinical trial NCT04656015: Cardiovascular Manifestation of Inflamatory Bowel Disease Patient ( Tissue Doppler Echocardiography and Cardiac MRI )
Official title: Cardiovascular Manifestation of Inflamatory Bowel Disease Patient ( Tissue Doppler Echocardiography and Cardiac MRI )
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac MRI in IBD Patient
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of cardiovascular affection in IBD patients
timeFrame: baseline
Secondary outcomes:
measure: Incidence of cardiovascular affection in IBD patients
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut univerty
name: Khaled Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.