CMR Imaging of Autoimmune Diseases

NCT ID: NCT04673409

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

123 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-24

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocarditis Autoimmune Rheumatologic Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Novel Cardiac MRI sequences

Intervention Type DIAGNOSTIC_TEST

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.

Novel Cardiac MRI sequences

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tevfik F. Ismail, PhD, FSCMR

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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20/L0/1076

Identifier Type: OTHER

Identifier Source: secondary_id

258879

Identifier Type: -

Identifier Source: org_study_id

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