MyocarditisPhase 4NCT05295290
A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.
A Phase 4 study testing Cardiac Imaging in people with Myocarditis, run by Pfizer at 18 sites in United States.
Trial summary
The purpose of this study is to learn about the safety and effects of the vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age <21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Read more about this study
- Who is it for?
- Ages 0 to 20 years
- Conditions the study is for
- Myocarditis
- What is being tested?
- Cardiac Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 18 sitesUnited States
- Study dates
- 21 Nov 2022to 2 Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cohort 1/2:
- Age <21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received any dose(s) of COMIRNATY within 21 days of symptom onset.
- Meets criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
Show all 22Show fewer
- Cohort 3:
- Age <21 years.
- Presentation to participating medical center with evaluation in Emergency Room and/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 to vaccination 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 on echocardiogram
- 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 findings consistent with myocarditis
- Capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
Who cannot join
- A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.
- Pre-existing cardiac conditions that could impact the primary endpoint, including but 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 of enrollment (or as determined by the local requirement).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Michigan Health Center
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, Georgia, 30329
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Michigan
Detroit, Michigan, 48201
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Memorial Healthcare System
Hollywood, Florida, 33021
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Childrens Mercy Kansas City
Kansas City, Missouri, 64108
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Valley Children's Hospital
Madera, California, 93636
Northwell Health-Cohen Children's Medical Center
New Hyde Park, New York, 11042
Children's Hospital
New Orleans, Louisiana, 70118
Columbia University Medical Center
New York, New York, 10032
MUSC Summey Medical Pavilion
North Charleston, South Carolina, 20406
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Childrens National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: LOW INTERVENTIONAL COHORT STUDY OF MYOCARDITIS/PERICARDITIS ASSOCIATED WITH COMIRNATY IN PERSONS LESS THAN 21 YEARS OF AGE
The purpose of this study is to learn about the safety and effects of the vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who:
- Are age <21 years.
- Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received any dose(s) of COMIRNATY within 21 days of symptom onset.
- Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
Read the detailed description
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 21 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment.
To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows:
Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or </= 2 weeks of hospital discharge.
Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled > 2 weeks after hospital discharge. Participants can be retrospectively ascertained and enrolled at any time from their COMIRNATY-associated myocarditis/pericarditis.
Cohort 3: Comparator cohort of COVID-19- related myocarditis/pericarditis , including MIS-C, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis. Cohort 3 participants will not be stratified by MIS-C diagnosis because of the rarity of myocardial involvement in children with acute severe COVID-19
Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)'s Pediatric Heart Network (PHN) and Pfizer.
Enrollment will include approximately 200 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).
- Conditions
- Myocarditis
- Being tested
- Cardiac Imaging
- Keywords
- COMIRNATY, post-vaccine, COVID-19, MIS-C
- Medical subject headings
- Myocarditis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac ImagingDiagnostic test
ECG, echocardiogram, ambulatory monitor, exercise stress test
| Study group | Role | What they receive |
|---|---|---|
| myocarditis/pericarditis following COMIRNATY | Other | myocarditis/pericarditis following COMIRNATY within 21 days of dose Receives: Diagnostic Test: Cardiac Imaging |
| myocarditis/pericarditis following COVID-19 or MIS-C | Other | myocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY Receives: Diagnostic Test: Cardiac Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite findings of myocarditis
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF < 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Measured: 6 months after illness onset
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Measured: Up to 5 years following illness onset.
Myocarditis by original or revised Lake Louise criteria on cMRI
Measured: Up to 5 years following illness onset.
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Measured: Up to 5 years following illness onset.
Complications, including non-cardiac morbidities by medical history
Measured: Up to 5 years following illness onset.
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Behavior Assessment System for Children, Third Edition (BASC-3), <8 yr (T score <30->70 with higher number meaning lower functioning) or PROMIS Short Forms ≥8 yr (scores from 3-15 with higher number meaning better functioning)
Measured: Up to 5 years following illness onset.
The Pediatric Quality of Life Inventory (PEDS QL)
The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to <18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning.
Measured: Up to 5 years following illness onset.
The Quality of Life Scale (QOLS)
The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants ≥18 years old.
Measured: Up to 5 years following illness onset.
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Measured: Up to 5 years following illness onset.
Secondary outcomes (14)
Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance.
Measured: During the hospitalization or within 2 weeks of hospital discharge, generally obtained less than 3 weeks from presentation.
Time to recovery of myocardial inflammation and injury by Lake Louise (the original or revised) criteria
Measured: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Measured: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Complications, including non-cardiac morbidities for myocarditis
Measured: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Echocardiographic LVEF
Measured: Up to 5 years following illness onset.
Myocardial inflammation scarring (by cMRI)
Measured: Up to 5 years following illness onset.
Arrhythmias on cardiac recordings
Measured: Up to 5 years following illness onset.
Complications, including non-cardiac morbidities by medical history
Measured: Up to 5 years following illness onset.
Lower LVEF by composite results
Identification of possible sociodemographic and medical risk factors for greater frequency and severity of acute and longer-term cardiac sequelae in participants, measured by ECG, original or revised Lake Louise criteria on cMRI, and presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Measured: Up to 5 years following illness onset.
For patients with isolated pericarditis, to determine time to recovery to normal.
Freedom from
- symptoms/signs of pericarditis;
- typical ECG findings of pericarditis;
- >small pericardial effusion;
- therapy with anti-inflammatory medications
Measured: At each study visit, up to 5 years, until the endpoint event is met
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Measured: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Conduction system disturbances on cardiac recordings
Measured: Up to 5 years following illness onset.
Freedom from the primary study endpoint ((The Primary Study Endpoint is the Composite Findings of Myocarditis and is described in Outcome Measure 1).
Measurement Schedule and Type of Assessment:
- Echocardiography: 2 weeks, 6 weeks, 6 months , and 1-5 years;
- cMRI: If ordered for routine clinical care, 6 months; annually at 1-5 years if previous study was abnormal;
- Exercise stress testing by 6 months; annually at 1-5 years if previous study was abnormal
Measured: 2 weeks, 6 weeks, 6 months, and 1-5 years
Time to recovery (return to normal) from the presence of abnormal LV strain parameters on echocardiography among those who had abnormalities at baseline
Measured: 2 weeks, 6 weeks, 6 months, and 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start21 Nov 2022
- Primary completion2 Apr 2029 (estimated)
- Study completion2 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295290
- Sponsor's protocol ID
- C4591036
- Other IDs
- NCT05295290
- Status last verified
- May 2026
- First submitted
- 10 Jan 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOW INTERVENTIONAL COHORT STUDY OF MYOCARDITIS/PERICARDITIS ASSOCIATED WITH COMIRNATY IN PERSONS LESS THAN 21 YEARS OF AGE
- ClinicalTrials.gov ID
- NCT05295290
- Acronym / sponsor ID
- C4591036
- Conditions
- Myocarditis
- Keywords
- COMIRNATY, post-vaccine, COVID-19, MIS-C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 319 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Carelon Research, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 2 Apr 2029 (estimated)
- Study completion
- 2 Apr 2029 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the safety and effects of the vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who:
- Are age <21 years.
- Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization.
- Received any dose(s) of COMIRNATY within 21 days of symptom onset.
- Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis
- Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent.
This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
Detailed description
This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.
To be classified as having COMIRNATY-associated myocarditis/pericarditis, a person must 1) meet the CDC case definition for probable or confirmed myocarditis/pericarditis, 2) have received any dose of COMIRNATY ≤ 21 days of symptom onset, and 3) have no other plausible alternative etiology at the time of enrollment.
To be classified as having myocarditis/pericarditis associated with COVID-19, a person must have 1) either acute severe COVID-19 infection or MIS-C, as defined by the CDC, 2) findings of probable or confirmed myocarditis in the CDC definition, 3) no other plausible alternative etiology. A description of the three cohorts is as follows:
Cohort 1: Prospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled under protocol during hospitalization or </= 2 weeks of hospital discharge.
Cohort 2: Retrospectively ascertained cases of probable or confirmed myocarditis/pericarditis associated with COMIRNATY , i.e., participants enrolled > 2 weeks after hospital discharge. Participants can be retrospectively ascertained and enrolled at any time from their COMIRNATY-associated myocarditis/pericarditis.
Cohort 3: Comparator cohort of COVID-19- related myocarditis/pericarditis , including MIS-C, both retrospectively and prospectively ascertained, and enrolled at any time from their COVID-19 or MIS-C associated myocarditis/pericarditis diagnosis. Cohort 3 participants will not be stratified by MIS-C diagnosis because of the rarity of myocardial involvement in children with acute severe COVID-19
Participants in all cohorts will be those who present to participating medical centers for care. This study is a collaboration between the National Heart, Lung, and Blood Institute (NHLBI)'s Pediatric Heart Network (PHN) and Pfizer.
Enrollment will include approximately 200 prospectively and retrospectively ascertained cases of children, adolescents, and young adults <21 years of age who receive care for myocarditis/pericarditis associated with COMIRNATY (Cohort 1 and 2); and approximately 100 persons <21 years of age with COVID -19-associated myocarditis/pericarditis, including MIS-C (Cohort 3).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myocarditis/pericarditis following COMIRNATY | Other | Diagnostic Test: Cardiac Imagingmyocarditis/pericarditis following COMIRNATY within 21 days of dose |
| myocarditis/pericarditis following COVID-19 or MIS-C | Other | Diagnostic Test: Cardiac Imagingmyocarditis/pericarditis following COVID-19 or MIS-C without exposure to COMIRNATY |
Who may qualify
- Ages
- 0 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- Cohort 1/2:
- Cohort 3:
Key exclusion criteria (6 listed)
- A plausible alternative etiology for myocarditis/pericarditis, as determined by the site based upon their routine clinical practice for evaluation of potential causes for myocarditis/pericarditis.
- Pre-existing cardiac conditions that could impact the primary endpoint, including but not limited to, documented history of left ventricular dysfunction (e.g., cardiomyopathy or myocardial infarction), pacemaker, or congenital heart disease, with the exceptions of:
- Previous administration with an investigational drug or vaccine within 30 days of enrollment (or as determined by the local requirement).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac ImagingECG, echocardiogram, ambulatory monitor, exercise stress test | Diagnostic test | myocarditis/pericarditis following COMIRNATY, myocarditis/pericarditis following COVID-19 or MIS-C |
Primary outcome
Composite findings of myocarditis
Time frame: 6 months after illness onset
This is a single composite primary outcome measure. This primary composite study endpoint is defined as the presence of 1 or more of the following 6 months after illness onset: left ventricular dysfunction (LVEF < 55% by echocardiogram), findings of myocarditis by original or revised Lake Louise criteria on cardiac MRI, or the presence of high-grade arrhythmia or conduction system disturbance on ECG or ambulatory monitoring.
Left ventricular ejection fraction (LVEF) < 55% by echocardiography
Time frame: Up to 5 years following illness onset.
Myocarditis by original or revised Lake Louise criteria on cMRI
Time frame: Up to 5 years following illness onset.
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Time frame: Up to 5 years following illness onset.
Complications, including non-cardiac morbidities by medical history
Time frame: Up to 5 years following illness onset.
Functional Status by Behavior Assessment System for Children, Third Edition BASC-3 or PROMIS Short Forms
Time frame: Up to 5 years following illness onset.
Behavior Assessment System for Children, Third Edition (BASC-3), <8 yr (T score <30->70 with higher number meaning lower functioning) or PROMIS Short Forms ≥8 yr (scores from 3-15 with higher number meaning better functioning)
The Pediatric Quality of Life Inventory (PEDS QL)
Time frame: Up to 5 years following illness onset.
The 27 question, age-appropriate and parent-proxy questionnaires, will be used in 2 to <18-year-old participants to assess quality of life. Scores span 0-108 with higher number being better functioning.
The Quality of Life Scale (QOLS)
Time frame: Up to 5 years following illness onset.
The QOLS, a 16-item self-report form that assesses overall quality of life on a scale of 16-112 (higher scores indicate better quality of life) will be administered for participants ≥18 years old.
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Time frame: Up to 5 years following illness onset.
14 secondary outcomes
Left ventricular ejection fraction (LVEF) by echocardiogram as a measure of myocardial performance.
Time frame: During the hospitalization or within 2 weeks of hospital discharge, generally obtained less than 3 weeks from presentation.
Time to recovery of myocardial inflammation and injury by Lake Louise (the original or revised) criteria
Time frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Arrhythmias on cardiac recording (ECG, ambulatory monitoring)
Time frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Complications, including non-cardiac morbidities for myocarditis
Time frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Echocardiographic LVEF
Time frame: Up to 5 years following illness onset.
Myocardial inflammation scarring (by cMRI)
Time frame: Up to 5 years following illness onset.
Arrhythmias on cardiac recordings
Time frame: Up to 5 years following illness onset.
Complications, including non-cardiac morbidities by medical history
Time frame: Up to 5 years following illness onset.
Lower LVEF by composite results
Time frame: Up to 5 years following illness onset.
For patients with isolated pericarditis, to determine time to recovery to normal.
Time frame: At each study visit, up to 5 years, until the endpoint event is met
Conduction system disturbances on cardiac recording (ECG, ambulatory monitoring)
Time frame: During hospitalization or within 2 weeks of hospital discharge, commonly less than 3 weeks from presentation
Conduction system disturbances on cardiac recordings
Time frame: Up to 5 years following illness onset.
Freedom from the primary study endpoint ((The Primary Study Endpoint is the Composite Findings of Myocarditis and is described in Outcome Measure 1).
Time frame: 2 weeks, 6 weeks, 6 months, and 1-5 years
Time to recovery (return to normal) from the presence of abnormal LV strain parameters on echocardiography among those who had abnormalities at baseline
Time frame: 2 weeks, 6 weeks, 6 months, and 1-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cardiac Imaging in people with Myocarditis, run by Pfizer at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite findings of myocarditis (time frame: 6 months after illness onset). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.