ClinicalTrials.gg
Not yet recruitingNCT05139329Updated Aug 28, 2025

The ORCHESTRATE-Myocarditis Registry

An observational study in Myocarditis, Ischemia and Chest Pain, sponsored by Kansas City Heart Rhythm Research Foundation. Not yet recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Kansas City Heart Rhythm Research Foundation · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
382
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Myocarditis
  • Ischemia
  • Chest Pain
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In context

Myocarditis

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's planned enrollment of 382 is above the median of 208 across 120 observational studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Kansas City Heart Rhythm Research Foundation is the lead sponsor of 29 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \<40%
  6. Previously documented history of pericarditis
  7. Previously documented history of costochondritis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
382 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

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What researchers measure

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.

    Time frame: 1/2014 - 1/2022

Secondary outcomes

  1. 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

    Time frame: 1/2014 - 1/2022

  2. Morbidity/mortality

    Assessment morbidity/mortality in this population

    Time frame: 1/2014 - 1/2022

  3. 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

    Time frame: 1/2014 - 1/2022

  4. Comparison of specific imaging modalities

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

    Time frame: 1/2014 - 1/2022

  5. 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

    Time frame: 1/2014 - 1/2022

  6. 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.

    Time frame: 1/2014 - 1/2022

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Study locations

4 sites
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References and documents

Publications

  • 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. PubMed 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, 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. PubMed 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. PubMed 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. PubMed 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: 10.1016/j.atherosclerosis.2015.04.816. Epub 2015 May 1. PubMed 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. PubMed 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. PubMed 31542534 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2026; primary completion for Mar 2026, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2021
First posted
Dec 1, 2021
StartEst.
Jan 2026
Primary completionEst.
Mar 2026
CompletionEst.
May 2026
Last update
Aug 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05139329
Lead sponsor
Kansas City Heart Rhythm Research Foundation
Collaborators
Kansas City Heart Rhythm Institute, Texas Cardiac Arrhythmia Research Foundation, Montefiore Medical Center, Loma Linda University
Responsible party
Sponsor
First posted
Dec 1, 2021
Start date
Jan 2026 (estimated)
Primary completion
Mar 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Aug 28, 2025

Study contacts

Donita Atkins
Contact
datkins@kchrf.com
816-651-1969
Dhanunjaya Lakkireddy, MD
principal investigator · Kansas City Heart Rhythm Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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