CASPA: CArdiac Sarcoidosis in PApworth

Study Overview
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Brief Summary
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Sarcoidosis is a disease of unknown cause which affects adults of all ethnic backgrounds. Clumps of tissue called granulomas develop primarily in the lungs, but can damage other organs, especially the heart. Anecdotal evidence from autopsy studies suggests the heart is affected in up to 68% of patients, but there is much uncertainty about this figure. If undetected and untreated, it can lead to serious complications or even sudden death. The current recommendation is to perform heart tracings (ECG s) on all patients, but this detects fewer than half of those with heart involvement. Blood markers traditionally used to diagnose heart disease are unreliable, meaning there is no simple blood test in use. The investigators propose a study with three aims. Firstly, identify the true prevalence of heart disease by performing Magnetic Resonance Imaging (MRI) scans on a group of patients with newly diagnosed lung sarcoidosis. Those found to have heart disease will have specialist (but routine) electrical heart tests. Secondly, (and perhaps the most immediate and clinically relevant) to identify the best method of diagnosing heart involvement using a combination of three simple tests: advanced ECG, 24-hour continuous ECG and a new type of computerised ultrasound scan. Thirdly, to identify proteins in the blood that could be used to develop a simple blood test for heart involvement in patients with lung sarcoidosis.

Official Title
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CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis

Conditions
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Interstitial Lung Disease, Pulmonary Sarcoidosis, Cardiac Sarcoidosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly referred adult patients with pulmonary sarcoidosis and diagnosis made at multidisciplinary meeting as per current joint BTS/ATS guidance Patient may be on ≤10mg prednisolone at time of recruitment (if already started at another site prior to referral). Able to give informed consent and able to comply with protocol ≥>18 yrs Exclusion Criteria: History of other cardiac disease (e.g. coronary artery disease)cardiac surgery or previous myocardial infarction (MI) Inability to give informed consent <18 yrs Patient may be on >10mg prednisolone at time of recruitment (if already started at another site prior to referral). On non-steroidal medication including methotrexate Pregnancy Alcoholism Illicit drug abuse Exclusion criteria for MRI: Cardiac pacemakers Surgical clips in the head (particularly aneurysm clips) Electronic inner ear implants (bionic ears) Ocular metal fragments • Electronic stimulators • Implanted pumps Severe claustrophobia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis | The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis | on Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine and Proteomic profiling | Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis | after 1 year | 
| Diagnosis of cardiac sarcoidosis | Diagnosis of cardiac sarcoidosis by combining signal averaged ECG, speckle tracking echocardiography and 24 hour holter monitoring | on Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcoidosis, cardiac, MRI, Echocardiography, pulmonary, cytokine