The ORCHESTRATE-Myocarditis Registry

August 27, 2025 updated by: Kansas City Heart Rhythm Research Foundation

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

382

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University International Heart Institute
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Heart Rhythm Institute
        • Contact:
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Institute at St. David's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1/2014 - 1/2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1/2014 - 1/2022
Morbidity/mortality
Time Frame: 1/2014 - 1/2022
Assessment morbidity/mortality in this population
1/2014 - 1/2022
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
1/2014 - 1/2022
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
1/2014 - 1/2022
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
1/2014 - 1/2022
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.
1/2014 - 1/2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Collaborators

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

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRF-ORCHESTRA-0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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