The ORCHESTRATE-Myocarditis Registry

Study Overview
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Brief Summary
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A retrospective, observational study consisting of patients who presents with typical/atypical chest pain and have an ensuing negative ischemic evaluation

Detailed Description
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Multicenter, retrospective, observational study consisting of patients who presents with typical/atypical chest pain to the emergency department and have an ensuing negative ischemic evaluation. Planned to review the subsequent diagnostic process in these patients, including patients with CMRI (Cardiac Magnetic Resonance Imaging), PET (Positron Emission Tomography) imaging for evaluation of myocarditis with the goal of quantifying the number of patients who go on to have a proven diagnosis of myocarditis that can explain their presenting symptoms.

Official Title
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Observational Registry of Ischemia Negative Chest Pain as the Presentation of Underlying Myocarditis: the ORCHESTRATE-Myocarditis Registry

Conditions
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Myocarditis, Ischemia, Chest Pain

Intervention / Treatment
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* Diagnostic Test: Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age >18 years Patients with a presentation of typical or atypical chest pain (ICD-10 Code R07.89, R07. 9) Patients with a negative ischemic workup: (including Coronary Artery Calcium Scoring/CTA, MPI, Nuclear Stress test, LHC/angiography showing anything greater than non-obstructive CAD) Exclusion criteria Patients with any evidence of positive ischemic workup as the cause of typical/atypical chest pain (as seen on Coronary Artery Calcium Scoring/CTA, MPI, Nuclear Stress test, LHC/angiography) Previously documented history of Prinzmetal angina or coronary vasospasm History of prior myocardial infarction History of any prior CAD with severity greater than non-obstructive CAD in all 3 coronary arteries History of LVEF<40% Previously documented history of pericarditis Previously documented history of costochondritis

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with symptoms of typical/atypical chest pain<br>Patients will be retrospectively included based on their presenting ICD codes or symptoms of typical/atypical chest pain, and those patients with positive ischemic workup will be excluded. The patients with negative ischemic workup will be included, and through chart review these patients will be followed to further assess their continued diagnostic workup. | Diagnostic Test: Imaging<br>* To better understand the prevalance of further imaging for evaluation of myocarditis, all patients with negative workup will be included and see what number of patients undergo further CMRI, FGD-PET, or speckle tracking echocardiography. Patients will then be categorized as those with myocarditis with positive diagnosis, negative diagnosis or unknown.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with unrecognized and underlying myocarditis | To quantify the number of patients with unrecognized and underlying myocarditis as a presentation of typical and atypical chest pain followed by a negative ischemic workup. | 1/2014 - 1/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of baseline characteristics or comorbidities with myocarditis | Identification of underlying baseline characteristics or comorbidities that have a greater association with myocarditis presenting as typical/atypical chest pain | 1/2014 - 1/2022 | 
| Morbidity/mortality | Assessment morbidity/mortality in this population | 1/2014 - 1/2022 | 
| Diagnostic timing for imaging modalities | Identification of most appropriate diagnostic timing for imaging modalities such as CMRI, FDG PET, speckle tracking echocardiography to diagnose myocarditis after initial negative ischemic workup | 1/2014 - 1/2022 | 
| Comparison of specific imaging modalities | Comparison of specific imaging modalities (CMRI vs FDG-PET vs speckle tracking echocardiography) and their diagnostic accuracy for myocarditis | 1/2014 - 1/2022 | 
| Imaging parameters that provide best diagnostic accuracy | Identification of specific imaging parameters on CMRI or PET imaging (late gadolinium enhancement, global dissynchrony measurements, global longitudinal strain, FDG uptake, etc) provide best diagnostic accuracy | 1/2014 - 1/2022 | 
| Imaging parameters that provide best outcome prediction for morbidity/mortality | Identification of specific imaging parameters on CMRI or PET imaging (late gadolinium enhancement, global dissynchrony measurements, global longitudinal strain, FDG uptake, etc) provide best outcome prediction for morbidity/mortality. | 1/2014 - 1/2022 |