CMR Imaging of Autoimmune Diseases

NCT04673409 | Unknown DMC

• 2 other identifiers: 25887920/L0/1076
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis; Autoimmune Rheumatologic Disease

Keywords

Cardiovascular Magnetic Resonance Imaging; Inflammation

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of novel versus conventional sequences

  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.

  2 weeks

Secondary Outcomes (3)

• Quantitative accuracy and precision of novel 3D sequences compared with conventional sequences

  2 weeks

• Acquisition time for both conventional and novel sequences versus conventional sequences

  2 weeks

• Proportion of diagnostic images with novel versus conventional sequences

  2 weeks

Study Arms (2)

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

Suspected myocarditis with autoimmune rheumatic disease

Patients with suspected myocarditis due to an underlying AIRD.

Diagnostic Test: Novel Cardiac MRI sequences

Interventions

Novel Cardiac MRI sequences 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 of undefined aetiology; Suspected myocarditis with autoimmune rheumatic disease

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Myocarditis; Inflammation

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tevfik F. Ismail, PhD, FSCMR

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 17, 2020
• Study Start: November 24, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 5, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)