ACAM2000® Myopericarditis Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01395082

Enrollment

Registered

2011-07-15

Start date

2011-04-30

Completion date

2019-02-04

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocarditis, Pericarditis

Keywords

Myocarditis, Pericarditis, Vaccinia virus, ACAM2000®, Smallpox vaccine

Brief summary

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.

Detailed description

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

17 Years to No maximum

Healthy volunteers

Yes

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.

Exclusion criteria

* Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.

Design outcomes

Primary

Measure	Time frame
The number of confirmed, probable, suspected, and subclinical cases of myopericarditis, categorized by time since vaccination	2 years after enrollment or after the last symptoms or positive findings

Other

Measure	Time frame
The natural history of myopericarditis in terms of time to resolution or change in status of myopericarditis and the pattern of changes in status of myopericarditis	2 years after enrollment or after the last symptoms or positive findings

Countries

United States

Outcome results