The ORCHESTRATE-Myocarditis Registry
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation
About this trial
A retrospective, observational study consisting of patients who presents with typical/atypical chest pain and have an ensuing negative ischemic evaluation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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")
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Imaging
Diagnostic testTo 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.
Treatment groups
382 Participants
are divided into 1 treatment groupGroup A: Patients with symptoms of typical/atypical chest pain1 intervention
Trial outcomes
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 - 1/2022Secondary 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 - 1/20222
Morbidity/mortality
Assessment morbidity/mortality in this population
Time frame
1/2014 - 1/20223
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 - 1/20224
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 - 1/2022Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kansas City Heart Rhythm Research Foundation
Lead sponsor
Kansas City Heart Rhythm Institute
Collaborator
Texas Cardiac Arrhythmia Research Foundation
Collaborator
Montefiore Medical Center
Collaborator
Loma Linda University International Heart Institute
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: