MyocarditisNCT05139329
The ORCHESTRATE-Myocarditis Registry
An observational study of Myocarditis and Ischemia, run by Kansas City Heart Rhythm Research Foundation at 4 sites in United States.
Trial summary
A retrospective, observational study consisting of patients who presents with typical/atypical chest pain and have an ensuing negative ischemic evaluation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis, Ischemia, Chest Pain
- What is being tested?
- Imaging
- How many people
- 382 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2026to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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")
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Texas Cardiac Arrhythmia Institute at St. David's Medical Center
Austin, Texas, 78705
Andrea Natale, MD, 512-807-3150, dr.natale@gmail.com
Loma Linda University International Heart Institute
Loma Linda, California, 92354
Jalaj Garg, MD, 585-766-0898, garg.jalaj@yahoo.com
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Dhanunjaya Lakkireddy, MD, 913-449-1297, dlakkireddy@gmail.com
Montefiore Medical Center
The Bronx, New York, 10467
Luigi Di Biase, MD, 718-920-4321, dibbia@gmail.com
About this study
Official title: Observational Registry of Ischemia Negative Chest Pain as the Presentation of Underlying Myocarditis: 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
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.
- Conditions
- Myocarditis, Ischemia, Chest Pain
- Being tested
- Imaging
- Medical subject headings
- Myocarditis, Ischemia, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1/2014 - 1/2022
Secondary outcomes (6)
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
Measured: 1/2014 - 1/2022
Morbidity/mortality
Assessment morbidity/mortality in this population
Measured: 1/2014 - 1/2022
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
Measured: 1/2014 - 1/2022
Comparison of specific imaging modalities
Comparison of specific imaging modalities (CMRI vs FDG-PET vs speckle tracking echocardiography) and their diagnostic accuracy for myocarditis
Measured: 1/2014 - 1/2022
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
Measured: 1/2014 - 1/2022
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.
Measured: 1/2014 - 1/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study startJan 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute, Texas Cardiac Arrhythmia Research Foundation, Montefiore Medical Center, Loma Linda University
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, MD, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139329
- Sponsor's protocol ID
- KCHRF-ORCHESTRA-0008
- Status last verified
- Aug 2025
- First submitted
- 17 Nov 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27884253Caforio 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 23824828Kindermann 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 22361396Kyto 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 26009575Tornvall 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 25967935Vago 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 32447308Karamitsos 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry of Ischemia Negative Chest Pain as the Presentation of Underlying Myocarditis: the ORCHESTRATE-Myocarditis Registry
- ClinicalTrials.gov ID
- NCT05139329
- Acronym / sponsor ID
- KCHRF-ORCHESTRA-0008
- Conditions
- Myocarditis, Ischemia, Chest Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Collaborators
- Kansas City Heart Rhythm Institute, Texas Cardiac Arrhythmia Research Foundation, Montefiore Medical Center, Loma Linda University
- Study start
- Jan 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptoms of typical/atypical chest pain | – | Diagnostic Test: ImagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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")
Key exclusion criteria (7 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingTo 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. | Diagnostic test | Patients with symptoms of typical/atypical chest pain |
Primary outcome
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.
6 secondary outcomes
Association of baseline characteristics or comorbidities with myocarditis
Time frame: 1/2014 - 1/2022
Morbidity/mortality
Time frame: 1/2014 - 1/2022
Diagnostic timing for imaging modalities
Time frame: 1/2014 - 1/2022
Comparison of specific imaging modalities
Time frame: 1/2014 - 1/2022
Imaging parameters that provide best diagnostic accuracy
Time frame: 1/2014 - 1/2022
Imaging parameters that provide best outcome prediction for morbidity/mortality
Time frame: 1/2014 - 1/2022
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 27884253Heymans 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.
- Background: PubMed 23824828Caforio 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.
- Background: PubMed 22361396Kindermann 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.
- Background: PubMed 26009575Kyto 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.
- Background: PubMed 25967935Tornvall 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.
- Background: PubMed 32447308Vago 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.
- Background: PubMed 31542534Karamitsos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dhanunjaya Lakkireddy, MD principal investigator
Kansas City Heart Rhythm Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis and Ischemia, run by Kansas City Heart Rhythm Research Foundation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donita Atkins (816-651-1969, datkins@kchrf.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with unrecognized and underlying myocarditis (time frame: 1/2014 - 1/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139329, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.