CClinicalTrials.gg
Status unknownNCT04656015Updated Dec 7, 2020

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

An observational study in Cardiac MRI in IBD Patient, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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
Read the 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 .

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Conditions studied

  • Cardiac MRI in IBD Patient

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03

In context

Intestinal Diseases

963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.

This study's planned enrollment of 100 is below the median of 140 across 377 observational studies indexed under Intestinal Diseases.

Browse Intestinal Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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)

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • DeviceMRI

    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

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What researchers measure

Primary outcomes

  1. Incidence of cardiovascular affection in IBD patients

    Incidence of cardiovascular affection in IBD patients

    Time frame: baseline

Secondary outcomes

  1. Incidence of cardiovascular affection in IBD patients

    Incidence of cardiovascular affection in IBD patients

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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. PubMed 31294387 ↗
  • 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. PubMed 24642015 ↗
  • 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. PubMed 26846643 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04656015
Lead sponsor
Assiut University
Responsible party
Mervat Sayed Kamal Sayed (resident doctor, Assiut University) — Principal investigator
First posted
Dec 7, 2020
Start date
Dec 1, 2020 (estimated)
Primary completion
Nov 30, 2021 (estimated)
Completion
Nov 30, 2021 (estimated)
Last update
Dec 7, 2020

Study contacts

Mervat Sayed
Contact
mervatsayed030@gmail.com
01018602654
Khaled Mohamed
principal investigator · Assiut univerty

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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