The ORCHESTRATE-Myocarditis Registry

Sponsor
Kansas City Heart Rhythm Research Foundation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05139329
Collaborator
Kansas City Heart Rhythm Institute (Other), Texas Cardiac Arrhythmia Research Foundation (Other), Montefiore Medical Center (Other), Loma Linda University International Heart Institute (Other)
382
4
3.9
95.5
24.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Imaging

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

Study Type:
Observational
Anticipated Enrollment :
382 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Observational Registry of Ischemia Negative Chest Pain as the Presentation of Underlying Myocarditis: the ORCHESTRATE-Myocarditis Registry
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Number of patients with unrecognized and underlying myocarditis [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.

Secondary Outcome Measures

  1. Association of baseline characteristics or comorbidities with myocarditis [1/2014 - 1/2022]

    Identification of underlying baseline characteristics or comorbidities that have a greater association with myocarditis presenting as typical/atypical chest pain

  2. Morbidity/mortality [1/2014 - 1/2022]

    Assessment morbidity/mortality in this population

  3. Diagnostic timing for imaging modalities [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

  4. Comparison of specific imaging modalities [1/2014 - 1/2022]

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

  5. Imaging parameters that provide best diagnostic accuracy [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

  6. Imaging parameters that provide best outcome prediction for morbidity/mortality [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University International Heart Institute Loma Linda California United States 92354
2 Kansas City Heart Rhythm Institute Overland Park Kansas United States 66211
3 Montefiore Medical Center Bronx New York United States 10467
4 Texas Cardiac Arrhythmia Institute at St. David's Medical Center Austin Texas United States 78705

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kansas City Heart Rhythm Research Foundation
ClinicalTrials.gov Identifier:
NCT05139329
Other Study ID Numbers:
  • KCHRF-ORCHESTRA-0008
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021