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CMR Imaging of Autoimmune Diseases

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ClinicalTrials.gov Identifier: NCT04673409
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Study Description
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Brief Summary:

Myocarditis is an important clinical problem which can can occur as a result of viral infections and autoimmune rheumatic diseases. Cardiac MRI is an important non-invasive means of making a diagnosis. However, current MRI techniques have significant limitations. Firstly, in order to create high-quality pictures, patients are required to hold their breath several times for multiple lengths of time. They often struggle with this due to underlying heart/lung problems. This can adversely affect the overall quality and image interpretation. Secondly, current techniques create 2D images that are potentially underestimating the presence and severity of any tissue inflammation/ injury. This may result in inappropriate treatment, particularly for patients with underlying autoimmune systemic disease who require immunosuppression.

Diagnosis by MRI rests on detecting tissue injury through T2 and T1-weighted sequences which detect tissue inflammation and tissue injury. The purpose of this study is to evaluate the diagnostic accuracy of novel 3D free-breathing sequences for T2-weighted and fibrosis/ LGE imaging.

Patients with suspected isolated myocarditis (viral/idiopathic) or myocarditis as part of an autoimmune systemic disease will be recruited to ensure that the novel techniques are tested in a broad spectrum of patients with inflammatory heart muscle disease.


Condition or disease Intervention/treatment
Myocarditis Autoimmune Rheumatologic Disease Diagnostic Test: Novel Cardiac MRI sequences

Study Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Multiparametric Tissue Characterisation of Myocardial Inflammation in Autoimmune Rheumatic Diseases (AIRD) Using Cardiovascular Magnetic Resonance Imaging
Actual Study Start Date : November 24, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Suspected myocarditis of undefined aetiology
Patients with signs and symptoms of acute myocarditis (as defined by the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases).
 Diagnostic Test: Novel Cardiac MRI sequences
Novel CMR sequences that allow accurate multiparametric evaluation of the whole myocardium with 3D high spatial resolution and in a patient-friendly free-breathing approach in a predictable amount of scanning time (3D T2 mapping and 3D anatomical and LGE imaging). This will be compared to the data acquired with conventional/2D sequences.
Suspected myocarditis with autoimmune rheumatic disease
Patients with suspected myocarditis due to an underlying AIRD.
 Diagnostic Test: Novel Cardiac MRI sequences
Novel CMR sequences that allow accurate multiparametric evaluation of the whole myocardium with 3D high spatial resolution and in a patient-friendly free-breathing approach in a predictable amount of scanning time (3D T2 mapping and 3D anatomical and LGE imaging). This will be compared to the data acquired with conventional/2D sequences.


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy of novel versus conventional sequences [ Time Frame: 2 weeks ]
    The CMR diagnosis of myocarditis will be made according to the revised (2018) Lake Louise criteria which mandate an increase in T2 (signal intensity in arbitrary units or absolute values in ms) and a T1-based marker (either absolute T1 in ms or LGE). T2-times and LGE from the novel 3D sequences will be combined as per revised Lake Louise criteria recommendations to make a diagnosis and compared with the conventional clinical sequences. A clinical diagnosis of cardiovascular inflammation will be made by an expert consensus adjudication panel initially based on evaluation of the patient's history and examination findings; ECG; the results of laboratory testing; and ancillary imaging findings. To avoid incorporation bias, the initial assessment will be blinded to tissue characterisation findings, and the classification will be compared between new and old methods using ROC analysis and the DeLong test.


Secondary Outcome Measures :
  1. Quantitative accuracy and precision of novel 3D sequences compared with conventional sequences [ Time Frame: 2 weeks ]
    The accuracy (bias) and precision (95% limits of agreement) of the novel 3D quantitative T2-mapping sequence will be assessed with the conventional 2D-values as a reference comparator using the methods of Bland and Altman. This will be used to derive the bias in measured T2 times in ms and the corresponding 95% limits of agreement (in ms).

  2. Acquisition time for both conventional and novel sequences versus conventional sequences [ Time Frame: 2 weeks ]
  3. Proportion of diagnostic images with novel versus conventional sequences [ Time Frame: 2 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the acute cardiology service and the rheumatology service referred for cardiovascular magnetic resonance imaging.
Criteria

Inclusion Criteria:

  • All patients referred for CMR for clinically suspected myocarditis either idiopathic or in the context of autoimmune rheumatic disease.
  • Patients who are able to give informed consent.

Exclusion Criteria:

  • Patients in atrial fibrillation.
  • Patients who are unable to give informed consent.
  • Patients whose physical or mental condition indicates that the additional time in the CMR scanner should be minimised.
  • Patients who cannot have CMR due to either contraindications to CMR (e.g., non-conditional intracardiac devices) or contraindications to contrast (e.g., history of allergy to gadolinium).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673409


Contacts
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Contact: Tevfik F. Ismail, PhD, FSCMR +442071885441 tevfik.ismail@kcl.ac.uk
Contact: Alina Hua, MBBS, MRCP alina.hua@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Tevfik F. Ismail, PhD, FSCMR    +442071885441    tevfik.ismail@kcl.ac.uk   
Contact: Alina Hua, MBBS, MRCP       alina.hua@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Tevfik F. Ismail, PhD, FSCMR King's College London
More Information
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04673409    
Other Study ID Numbers: 258879
20/L0/1076 ( Other Identifier: Research Ethics Committee (United Kingdom) )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Cardiovascular Magnetic Resonance Imaging
Inflammation
Additional relevant MeSH terms:
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Rheumatic Diseases
Myocarditis
Collagen Diseases
Cardiomyopathies
 Heart Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Musculoskeletal Diseases