MyocarditisNCT04673409
CMR Imaging of Autoimmune Diseases
An observational study of Myocarditis and Autoimmune Rheumatologic Disease, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocarditis, Autoimmune Rheumatologic Disease
- What is being tested?
- Novel Cardiac MRI sequences
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2020to 30 Jun 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients will be recruited from the acute cardiology service and the rheumatology service referred for cardiovascular magnetic resonance imaging.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Multiparametric Tissue Characterisation of Myocardial Inflammation in Autoimmune Rheumatic Diseases (AIRD) Using Cardiovascular Magnetic Resonance Imaging
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
- Being tested
- Novel Cardiac MRI sequences
- Keywords
- Cardiovascular Magnetic Resonance Imaging, Inflammation
- Medical subject headings
- Myocarditis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Cardiac MRI sequencesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Novel Cardiac MRI sequences | |
| Suspected myocarditis with autoimmune rheumatic disease | Patients with suspected myocarditis due to an underlying AIRD. Receives: Diagnostic Test: Novel Cardiac MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (3)
Quantitative accuracy and precision of novel 3D sequences compared with conventional sequences
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).
Measured: 2 weeks
Acquisition time for both conventional and novel sequences versus conventional sequences
Measured: 2 weeks
Proportion of diagnostic images with novel versus conventional sequences
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start24 Nov 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tevfik F. Ismail, PhD, FSCMR, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673409
- Sponsor's protocol ID
- 258879
- Other IDs
- 20/L0/1076
- Status last verified
- Oct 2023
- First submitted
- 30 Nov 2020
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No