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The ORCHESTRATE-Myocarditis Registry

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05139329
Enrollment
382
Registered
2021-12-01
Start date
2026-01-31
Completion date
2026-05-31
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Ischemia, Myocarditis

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTImaging

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.

Sponsors

Kansas City Heart Rhythm Institute
CollaboratorOTHER
Texas Cardiac Arrhythmia Research Foundation
CollaboratorOTHER
Montefiore Medical Center
CollaboratorOTHER
Loma Linda University International Heart Institute
CollaboratorUNKNOWN
Kansas City Heart Rhythm Research Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with unrecognized and underlying myocarditis1/2014 - 1/2022To 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

MeasureTime frameDescription
Morbidity/mortality1/2014 - 1/2022Assessment morbidity/mortality in this population
Diagnostic timing for imaging modalities1/2014 - 1/2022Identification of most appropriate diagnostic timing for imaging modalities such as CMRI, FDG PET, speckle tracking echocardiography to diagnose myocarditis after initial negative ischemic workup
Association of baseline characteristics or comorbidities with myocarditis1/2014 - 1/2022Identification of underlying baseline characteristics or comorbidities that have a greater association with myocarditis presenting as typical/atypical chest pain
Imaging parameters that provide best diagnostic accuracy1/2014 - 1/2022Identification 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/mortality1/2014 - 1/2022Identification 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.
Comparison of specific imaging modalities1/2014 - 1/2022Comparison of specific imaging modalities (CMRI vs FDG-PET vs speckle tracking echocardiography) and their diagnostic accuracy for myocarditis

Countries

United States

Contacts

Primary ContactDonita Atkins
datkins@kchrf.com816-651-1969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026