The ORCHESTRATE-Myocarditis Registry

Chest Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05139329
• Other study ID #: KCHRF-ORCHESTRA-0008
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: May 2022

Study information

• Verified date: November 2021
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 382
• Est. completion date: May 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Age >18 years

2. Patients with a presentation of typical or atypical chest pain (ICD-10 Code R07.89, R07. 9)

3. 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

1. 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)

2. Previously documented history of Prinzmetal angina or coronary vasospasm

3. History of prior myocardial infarction

4. History of any prior CAD with severity greater than "non-obstructive CAD" in all 3 coronary arteries

5. History of LVEF<40%

6. Previously documented history of pericarditis

7. Previously documented history of costochondritis

Related Conditions & MeSH terms

• Chest Pain
• Ischemia
• Myocarditis

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Institute at St. David's Medical Center	Austin	Texas
United States	Montefiore Medical Center	Bronx	New York
United States	Loma Linda University International Heart Institute	Loma Linda	California
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (5)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Kansas City Heart Rhythm Institute, Loma Linda University International Heart Institute, Montefiore Medical Center, Texas Cardiac Arrhythmia Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Morbidity/mortality	Assessment morbidity/mortality in this population	1/2014 - 1/2022
Secondary	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
Secondary	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
Secondary	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
Secondary	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