ACAM2000® Myopericarditis Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2019-02-04

Brief Summary

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The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.

Primary Objective:

\- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.

Other Pre-defined Objective:

\- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.

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Detailed Description

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All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).

Conditions

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Myocarditis Pericarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Entire registry group

Participants with potential myopericarditis cases referred to the Registry

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
* Documented vaccination with ACAM2000® vaccine
* Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.