The ORCHESTRATE-Myocarditis Registry

NCT ID: NCT05139329

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

382 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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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

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Myocarditis Ischemia Chest Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Imaging

Intervention Type 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.

Interventions

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Imaging

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kansas City Heart Rhythm Institute

OTHER

Sponsor Role collaborator

Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role collaborator

Loma Linda University International Heart Institute

UNKNOWN

Sponsor Role collaborator

Kansas City Heart Rhythm Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dhanunjaya Lakkireddy, MD

Role: PRINCIPAL_INVESTIGATOR

Kansas City Heart Rhythm Institute

Locations

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Loma Linda University International Heart Institute

Loma Linda, California, United States

Site Status

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

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

Austin, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Donita Atkins

Role: CONTACT

816-651-1969

Facility Contacts

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Jalaj Garg, MD

Role: primary

585-766-0898

Dhanunjaya Lakkireddy, MD

Role: primary

913-449-1297

Luigi Di Biase, MD

Role: primary

718-920-4321

Andrea Natale, MD

Role: primary

512-807-3150

References

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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.

Reference Type BACKGROUND
PMID: 27884253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23824828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22361396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26009575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25967935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32447308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31542534 (View on PubMed)

Other Identifiers

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KCHRF-ORCHESTRA-0008

Identifier Type: -

Identifier Source: org_study_id

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