Phase
Condition
Chest Pain
Dermatomyositis (Connective Tissue Disease)
Treatment
Cardiac Imaging
Clinical Study ID
Ages < 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Cohort 1/2:
Age <21 years.
Presentation to participating medical center with evaluation in Emergency Roomand/or hospitalization.
Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 28days of symptom onset.
Meets criteria of Centers for Disease Control and Prevention case definition ofprobable or confirmed myocarditis/pericarditis
Capable of giving signed informed consent/assent (by parents/legal guardians ofminors and/or patients), which includes compliance with the requirements andrestrictions listed in the Informed Consent/Assent Document and in thisprotocol OR meets criteria for waiver of consent.
- Cohort 3:
Age <21 years.
Presentation to participating medical center with evaluation in Emergency Roomand/or hospitalization.
COVID-19-related disease
Acute COVID-19 infection OR
Multi-system Inflammatory Syndrome in Children Associated with COVID-19 (MIS-C) AND
Probable or confirmed myocarditis/pericarditis* not temporally related tovaccination with COMINARTY
Probable myocarditis/pericarditis as defined by ≥ 1 new finding of:
- Elevated troponin above upper limit of normal
- Abnormal ECG or rhythm monitoring finding consistent with myocarditis
- Abnormal cardiac function or wall motion abnormalities onechocardiogram
- cMRI findings consistent with myocarditis OR
- Confirmed myocarditis/pericarditis as defined by:
- Histopathologic confirmation of myocarditis OR
- Elevated troponin above upper limit of normal AND cMRI findingsconsistent with myocarditis
- Capable of giving signed informed consent/assent (by parents/legal guardians ofminors and/or patients), which includes compliance with the requirements andrestrictions listed in the Informed Consent/Assent Document and in thisprotocol OR meets criteria for waiver of consent.
Exclusion
Exclusion Criteria:
A plausible alternative etiology for myocarditis/pericarditis, as determined by thesite based upon their routine clinical practice for evaluation of potential causesfor myocarditis/pericarditis.
Pre-existing cardiac conditions that could impact the primary endpoint, includingbut not limited to, documented history of left ventricular dysfunction (e.g.,cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease,with the exceptions of:
Bicommissural aortic valve with < trivial stenosis and/or insufficiency
Mitral valve prolapse with < trivial insufficiency
Hemodynamically insignificant atrial septal or ventricular septal defects.
Previous administration with an investigational drug or vaccine within 30 days ofenrollment (or as determined by the local requirement).
Study Design
Study Description
Connect with a study center
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Children's of Alabama
Birmingham, Alabama 35233
United StatesActive - Recruiting
Phoenix Children's Hospital
Phoenix, Arizona 85016
United StatesActive - Recruiting
Childrens Hospital Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
Valley Children's Hospital
Madera, California 93636
United StatesActive - Recruiting
Lucile Packard Children's Hospital Stanford
Palo Alto, California 94304
United StatesActive - Recruiting
Childrens Hospital of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesActive - Recruiting
Nemours Children's Hospital, Delaware
Wilmington, Delaware 19803
United StatesActive - Recruiting
Childrens National Hospital
Washington, District of Columbia 20010
United StatesActive - Recruiting
Memorial Healthcare System
Hollywood, Florida 33021
United StatesActive - Recruiting
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia 30322
United StatesActive - Recruiting
Lurie Children's Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Indiana University
Indianapolis, Indiana 46202-5225
United StatesActive - Recruiting
Indiana University School of Medicine
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Children's Hospital
New Orleans, Louisiana 70118
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
University of Michigan Hospital-Mott Children's Hospital
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Children's Hospital of Michigan
Detroit, Michigan 48201
United StatesActive - Recruiting
Children'S Hospitals & Clinics of Minn
Minneapolis, Minnesota 55404
United StatesActive - Recruiting
Children's Minnesota
Minneapolis, Minnesota 55404
United StatesSite Not Available
Childrens Mercy Kansas City
Kansas City, Missouri 64108
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Northwell Health-Cohen Children's Medical Center
New Hyde Park, New York 11042
United StatesActive - Recruiting
Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Duke University Hospital
Durham, North Carolina 27710
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Medical University of South Carolina (Musc) - Children's Hospital
Charleston, South Carolina 29425
United StatesActive - Recruiting
Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital
Charleston, South Carolina 29425
United StatesActive - Recruiting
Baylor College Of Medicine (Bcm) - Texas Children's Hospital (Tch)
Houston, Texas 77030-2316
United StatesActive - Recruiting
Texas Children's Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Primary Children's
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Primary Children's Hospital
Salt Lake City, Utah 84113
United StatesActive - Recruiting
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
Seattle Children's Hospital & Research Institute
Seattle, Washington 98101
United StatesActive - Recruiting
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