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NCT Number: NCT05139329

The ORCHESTRATE-Myocarditis Registry

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

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Key information

Conditions

Myocarditis Cardiomyopathies Cardiovascular Diseases Chest Pain Heart Diseases Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University International Heart Institute, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of patients with unrecognized and underlying myocarditis

    Time frame: 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 outcomes

  1. Association of baseline characteristics or comorbidities with myocarditis

    Time frame: 1/2014 - 1/2022

    Identification of underlying baseline characteristics or comorbidities that have a greater association with myocarditis presenting as typical/atypical chest pain

  2. Morbidity/mortality

    Time frame: 1/2014 - 1/2022

    Assessment morbidity/mortality in this population

  3. Diagnostic timing for imaging modalities

    Time frame: 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

  4. Comparison of specific imaging modalities

    Time frame: 1/2014 - 1/2022

    Comparison of specific imaging modalities (CMRI vs FDG-PET vs speckle tracking echocardiography) and their diagnostic accuracy for myocarditis

  5. Imaging parameters that provide best diagnostic accuracy

    Time frame: 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

  6. Imaging parameters that provide best outcome prediction for morbidity/mortality

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Donita Atkins

CONTACT

[email protected]

816-651-1969

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2021
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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