ACAM2000® Myopericarditis Registry
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 17 - Any |
| Updated: | 3/16/2019 |
| Start Date: | April 2011 |
| End Date: | February 4, 2019 |
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.
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.
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).
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).
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.
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