The ORCHESTRATE-Myocarditis Registry
Study Details
Study Description
Brief Summary
A retrospective, observational study consisting of patients who presents with typical/atypical chest pain and have an ensuing negative ischemic evaluation
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Patients with symptoms of typical/atypical chest pain 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
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.
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Outcome Measures
Primary Outcome Measures
- Number of patients with unrecognized and underlying myocarditis [1/2014 - 1/2022]
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.
Secondary Outcome Measures
- Association of baseline characteristics or comorbidities with myocarditis [1/2014 - 1/2022]
Identification of underlying baseline characteristics or comorbidities that have a greater association with myocarditis presenting as typical/atypical chest pain
- Morbidity/mortality [1/2014 - 1/2022]
Assessment morbidity/mortality in this population
- Diagnostic timing for imaging modalities [1/2014 - 1/2022]
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
- Comparison of specific imaging modalities [1/2014 - 1/2022]
Comparison of specific imaging modalities (CMRI vs FDG-PET vs speckle tracking echocardiography) and their diagnostic accuracy for myocarditis
- Imaging parameters that provide best diagnostic accuracy [1/2014 - 1/2022]
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
- Imaging parameters that provide best outcome prediction for morbidity/mortality [1/2014 - 1/2022]
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.
Eligibility Criteria
Criteria
Inclusion criteria
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Age >18 years
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Patients with a presentation of typical or atypical chest pain (ICD-10 Code R07.89, R07. 9)
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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
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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)
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Previously documented history of Prinzmetal angina or coronary vasospasm
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History of prior myocardial infarction
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History of any prior CAD with severity greater than "non-obstructive CAD" in all 3 coronary arteries
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History of LVEF<40%
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Previously documented history of pericarditis
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Previously documented history of costochondritis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Loma Linda University International Heart Institute | Loma Linda | California | United States | 92354 |
2 | Kansas City Heart Rhythm Institute | Overland Park | Kansas | United States | 66211 |
3 | Montefiore Medical Center | Bronx | New York | United States | 10467 |
4 | Texas Cardiac Arrhythmia Institute at St. David's Medical Center | Austin | Texas | United States | 78705 |
Sponsors and Collaborators
- Kansas City Heart Rhythm Research Foundation
- Kansas City Heart Rhythm Institute
- Texas Cardiac Arrhythmia Research Foundation
- Montefiore Medical Center
- Loma Linda University International Heart Institute
Investigators
- Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Heliö T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
- Heymans S, Eriksson U, Lehtonen J, Cooper LT Jr. The Quest for New Approaches in Myocarditis and Inflammatory Cardiomyopathy. J Am Coll Cardiol. 2016 Nov 29;68(21):2348-2364. doi: 10.1016/j.jacc.2016.09.937. Review.
- Karamitsos TD, Arvanitaki A, Karvounis H, Neubauer S, Ferreira VM. Myocardial Tissue Characterization and Fibrosis by Imaging. JACC Cardiovasc Imaging. 2020 May;13(5):1221-1234. doi: 10.1016/j.jcmg.2019.06.030. Epub 2019 Sep 18. Review.
- Kindermann I, Barth C, Mahfoud F, Ukena C, Lenski M, Yilmaz A, Klingel K, Kandolf R, Sechtem U, Cooper LT, Böhm M. Update on myocarditis. J Am Coll Cardiol. 2012 Feb 28;59(9):779-92. doi: 10.1016/j.jacc.2011.09.074. Review.
- Kytö V, Sipilä J, Rautava P. Acute myocardial infarction or acute myocarditis? Discharge registry-based study of likelihood and associated features in hospitalised patients. BMJ Open. 2015 May 25;5(5):e007555. doi: 10.1136/bmjopen-2014-007555.
- Tornvall P, Gerbaud E, Behaghel A, Chopard R, Collste O, Laraudogoitia E, Leurent G, Meneveau N, Montaudon M, Perez-David E, Sörensson P, Agewall S. Myocarditis or "true" infarction by cardiac magnetic resonance in patients with a clinical diagnosis of myocardial infarction without obstructive coronary disease: A meta-analysis of individual patient data. Atherosclerosis. 2015 Jul;241(1):87-91. doi: 10.1016/j.atherosclerosis.2015.04.816. Epub 2015 May 1. Review.
- Vágó H, Szabó L, Dohy Z, Czimbalmos C, Tóth A, Suhai FI, Bárczi G, Gyarmathy VA, Becker D, Merkely B. Early cardiac magnetic resonance imaging in troponin-positive acute chest pain and non-obstructed coronary arteries. Heart. 2020 Jul;106(13):992-1000. doi: 10.1136/heartjnl-2019-316295. Epub 2020 May 23.
- KCHRF-ORCHESTRA-0008