Incidence, Patient Characteristics & Outcome of Myocarditis After COVID-19

Status Completed

Clinical Trial Summary

This study evaluates the incidence, patient characteristics and outcome of myocarditis after the COVID-19 mRNA vaccination in healthcare professionals.

Clinical Trial Description

Considering previous reports of cardiovascular adverse events, passive surveillance might not identify all myocarditis/myopericarditis cases after COVID-19 vaccination and it is possible that a mild/subclinical myocarditis might be much more prevalent in the population. This research project has three aims: first, provide novel insights regarding the incidence, patient characteristics and outcome of myocarditis. Second, provide a safety net by active surveillance for myocarditis, allowing early initiation of appropriate therapy. Third, provide reassurance to the public regarding myocarditis, as questions have been raised by critics of the pharmaceutical industry that Phase III studies performed by the pharmaceutical industry may have not appropriately captured adverse events. This study is screening persons undergoing the COVID-19 mRNA booster vaccination of possible development of myocarditis. This approach in detecting myocarditis would help early initiation of the right treatment under close monitoring of the clinical course. Furthermore, this kind of study might also help understand the development of myocarditis and possibly the reasons for sex differences. Myocarditis suspicion is raised when patients present symptoms of acute chest discomfort, myalgia, fever/chills, abnormal ECG, increased concentrations of high-sensitivity cardiac troponin T (hs-cTnT), possibly supported by signs of cardiac inflammation in cMRI (myocardial oedema, myocardial/pericardial late gadolinium enhancement, pericardial effusion). Since the study is performed on health care professionals working in the University Hospital Basel, it is able to monitor more closely the possible side effects of the mRNA vaccination. Consecutive individuals that received a COVID-19 mRNA vaccine booster and undergo a systematic approach to detect myocarditis at the University Hospital Basel will be included. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05438472
Study type	Observational
Source	University Hospital, Basel, Switzerland
Contact
Status	Completed
Phase
Start date	December 10, 2021
Completion date	April 20, 2022

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05911386` - Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
Not yet recruiting	`NCT04085718` - FDG-PET/CT Images Comparing to MRI and Endomyocardial Biopsy in Myocarditis
Enrolling by invitation	`NCT05610423` - Covid-19 Vaccine Associated Myocarditis and Pericarditis in Norway
Active, not recruiting	`NCT05195645` - AbataCept for the Treatment of Immune-cHeckpoint Inhibitors Induced mYocarditiS	Phase 2
Recruiting	`NCT05184114` - Clinical Significance of Subclinical Myocardial Involvement in Recovered COVID-19 Patients Using Cardiovascular Magnetic Resonance	N/A
Recruiting	`NCT04612296` - The Heart Hive - Cardiomyopathy Study
Recruiting	`NCT04673409` - CMR Imaging of Autoimmune Diseases
Recruiting	`NCT05295290` - A Study to Learn About The COVID-19 (Study) Vaccine (Called COMIRNATY) in People That Are Less Than 21 Years Old.	Phase 4
Completed	`NCT03777839` - PET-FDG in Myocarditis
Completed	`NCT06447935` - Acute Eosinophilic Myocarditis International Registry
Not yet recruiting	`NCT05125965` - Contribution of Cardiac MRI in the Early Diagnosis of Myocarditis Induced by Immunotherapy	N/A
Active, not recruiting	`NCT04444128` - IMPRoving Cardiovascular RiSk Stratification Using T1 Mapping in General populatION
Recruiting	`NCT06158698` - CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine	Phase 3
Recruiting	`NCT05282498` - Pathophysiologic Mechanism for MYOcarditis in COVID19 VAccinations ("MYOVAx" Study)
Recruiting	`NCT05288426` - Myocarditis Post Vaccination or Multi System Inflammatory Syndrome
Recruiting	`NCT03801681` - ARrhythmias in MYocarditis
Recruiting	`NCT06116084` - Randomized Controlled Study Evaluating the Efficacy of Hypnosis in Nuclear Medicine	N/A
Completed	`NCT04413071` - Cardiac COVID-19 Health Care Workers
Recruiting	`NCT05414162` - Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy
Recruiting	`NCT06409585` - Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Incidence, Patient Characteristics and Outcome of Myocarditis After COVID-19 mRNA Vaccine — MACIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms