Clinical trial NCT04673409: CMR Imaging of Autoimmune Diseases
Official title: Multiparametric Tissue Characterisation of Myocardial Inflammation in Autoimmune Rheumatic Diseases (AIRD) Using Cardiovascular Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myocarditis
Autoimmune Rheumatologic Disease
Keywords: Cardiovascular Magnetic Resonance Imaging
Inflammation
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2020-12-17
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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).

Primary outcomes:
measure: Diagnostic accuracy of novel versus conventional sequences
timeFrame: 2 weeks
Secondary outcomes:
measure: Quantitative accuracy and precision of novel 3D sequences compared with conventional sequences
timeFrame: 2 weeks
measure: Acquisition time for both conventional and novel sequences versus conventional sequences
timeFrame: 2 weeks
measure: Proportion of diagnostic images with novel versus conventional sequences
timeFrame: 2 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Tevfik F. Ismail, PhD, FSCMR
role: PRINCIPAL_INVESTIGATOR
References: