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

NCT04656015 | Unknown

• 1 other identifier: cardiac MRI in IBD patient
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Evaluation of cardiovascular changes using Doppler echocardiography and cardiac MRI in IBD patients
2. 2.To detect the frequency of myocardial injury in IBD patients
3. 3.To detect the sensitivity and specificity of echocardiography for the detection of cardiac injury in comparison to cardiac MRI in IBD patients

Conditions

Cardiac MRI in IBD Patient

Outcome Measures

Primary Outcomes (1)

• Incidence of cardiovascular affection in IBD patients

  Incidence of cardiovascular affection in IBD patients

  baseline

Secondary Outcomes (1)

• Incidence of cardiovascular affection in IBD patients

  baseline

Interventions

MRI DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 31294387 BACKGROUND

• 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.

  PMID: 24642015 BACKGROUND

• 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.

  PMID: 26846643 BACKGROUND

Study Officials

• Khaled Mohamed

  Assiut univerty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mervat Sayed

CONTACT

01018602654; mervatsayed030@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 7, 2020
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 7, 2020

Record last verified: 2020-11