The ORCHESTRATE-Myocarditis Registry

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Number of patients with unrecognized and underlying myocarditis [Срок оценки: 1/2014 - 1/2022]

Вторичные конечные точки (6)

• Association of baseline characteristics or comorbidities with myocarditis [Срок оценки: 1/2014 - 1/2022]
• Morbidity/mortality [Срок оценки: 1/2014 - 1/2022]
• Diagnostic timing for imaging modalities [Срок оценки: 1/2014 - 1/2022]
• Comparison of specific imaging modalities [Срок оценки: 1/2014 - 1/2022]
• Imaging parameters that provide best diagnostic accuracy [Срок оценки: 1/2014 - 1/2022]
• Imaging parameters that provide best outcome prediction for morbidity/mortality [Срок оценки: 1/2014 - 1/2022]

Критерии участия

Критерии включения

• 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")

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 4 центра

• Loma Linda University International Heart Institute — Loma Linda
• Kansas City Heart Rhythm Institute — Overland Park
• Montefiore Medical Center — The Bronx
• Texas Cardiac Arrhythmia Institute at St. David's Medical Center — Austin

Публикации

• 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. PMID 27884253
• Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio 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, diagnos PMID 23824828
• Kindermann I, Barth C, Mahfoud F, Ukena C, Lenski M, Yilmaz A, Klingel K, Kandolf R, Sechtem U, Cooper LT, Bohm M. Update on myocarditis. J Am Coll Cardiol. 2012 Feb 28;59(9):779-92. doi: 10.1016/j.jacc.2011.09.074. PMID 22361396
• Kyto V, Sipila 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. PMID 26009575
• Tornvall P, Gerbaud E, Behaghel A, Chopard R, Collste O, Laraudogoitia E, Leurent G, Meneveau N, Montaudon M, Perez-David E, Sorensson 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 PMID 25967935
• Vago H, Szabo L, Dohy Z, Czimbalmos C, Toth A, Suhai FI, Barczi 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. PMID 32447308
• 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. PMID 31542534

Идентификаторы

NCT: NCT05139329 · KCHRF-ORCHESTRA-0008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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