The ORCHESTRATE-Myocarditis Registry

NCT05139329 | Not Yet Recruiting

• 1 other identifier: KCHRF-ORCHESTRA-0008
• Study Type: observational
• Target: 382
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myocarditis; Ischemia; Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Association of baseline characteristics or comorbidities with myocarditis

  1/2014 - 1/2022

• Morbidity/mortality

  1/2014 - 1/2022

• Diagnostic timing for imaging modalities

  1/2014 - 1/2022

• Comparison of specific imaging modalities

  1/2014 - 1/2022

• Imaging parameters that provide best diagnostic accuracy

  1/2014 - 1/2022

Study Arms (1)

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

Interventions

Imaging DIAGNOSTIC_TEST

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.

Patients with symptoms of typical/atypical chest pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients \>18 years of age will be included. Given the retrospective nature of this study, patients will be enrolled via chart review based upon their ICD-10 codes of chest pain on ER presentation, and these patients will be followed via chart review until a diagnosis is made. Males and females with a presentation of atypical chest pain and following a negative ischemic evaluation will be enrolled if they meet the inclusion/exclusion criteria.

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead
• Kansas City Heart Rhythm Institute: collaborator
• Texas Cardiac Arrhythmia Research Foundation: collaborator
• Montefiore Medical Center: collaborator
• Loma Linda University International Heart Institute: collaborator

Study Sites (4)

Loma Linda University International Heart Institute

Loma Linda, California, 92354, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Austin, Texas, 78705, United States

Location

Related Publications (7)

• 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 BACKGROUND

• 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, 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.

  PMID: 23824828 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1016/j.atherosclerosis.2015.04.816. Epub 2015 May 1.

  PMID: 25967935 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Myocarditis; Ischemia; Chest Pain

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dhanunjaya Lakkireddy, MD

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donita Atkins

CONTACT

816-651-1969; datkins@kchrf.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)