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CMR Imaging of Autoimmune Diseases

K

King's College London

Status

Active, not recruiting

Conditions

Myocarditis
Autoimmune Rheumatologic Disease

Treatments

Diagnostic Test: Novel Cardiac MRI sequences

Study type

Observational

Funder types

Other

Identifiers

NCT04673409
20/L0/1076 (Other Identifier)
258879

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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).

Trial design

123 participants in 2 patient groups

Suspected myocarditis of undefined aetiology
Description:
Patients with signs and symptoms of acute myocarditis (as defined by the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases).
Treatment:
Diagnostic Test: Novel Cardiac MRI sequences
Suspected myocarditis with autoimmune rheumatic disease
Description:
Patients with suspected myocarditis due to an underlying AIRD.
Treatment:
Diagnostic Test: Novel Cardiac MRI sequences

Trial contacts and locations

1

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Central trial contact

Tevfik F. Ismail, PhD, FSCMR; Alina Hua, MBBS, MRCP

Data sourced from clinicaltrials.gov

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