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

Cardiac MRI in IBD Patient Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04656015
• Other study ID #: cardiac MRI in IBD patient
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: Mervat Sayed
• Phone: 01018602654
• Email: mervatsayed030[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac MRI in IBD Patient
• Intestinal Diseases

Intervention

Device:
• MRI
cMRI will be done only to patients presented with signs of HF, with raised cardiac biomarkers and echocardiographic signs of myocardial injury The Lake Louise diagnostic criteria for CMR in myocarditis: CMR findings are consistent with myocardial inflammation if at least two of the following criteria are present: Regional or global myocardial signal intensity increase in T2-weighted images Increased global myocardial early gadolinium enhancement ratio between myocardium and skeletal muscle in gadolinium-enhanced T1-weighted images There is at least one focal lesion with non-ischemic regional distribution on late gadolinium enhancement Presence of left ventricular dysfunction or pericardial effusion provides additional, supportive evidence for myocarditis 6. Carotid du

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cardiovascular affection in IBD patients	Incidence of cardiovascular affection in IBD patients	baseline
Secondary	Incidence of cardiovascular affection in IBD patients	Incidence of cardiovascular affection in IBD patients	baseline