Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06103123
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-05-29
Brief Title:
MYocarditis andor Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
MYocarditis andor Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MYCOVACC
Brief Summary:
Myocarditis is inflammation of the heart muscle Pericarditis is inflammation of the lining surrounding the heart muscle Symptoms of these conditions can include pain in the chest and rapid or irregular heartbeat There are many different causes for myocarditis and pericarditis including COVID-19 infection
The MYCOVACC study will identify patients using local screening strategies including research communications care provider referrals and medical record review The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis Consenting patients will then be prospectively followed according to standard of care protocols The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events functional outcomes including quality of life and myocardial recovery through imaging
The MYCOVACC study will identify patients using local screening strategies including research communications care provider referrals and medical record review The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis Consenting patients will then be prospectively followed according to standard of care protocols The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events functional outcomes including quality of life and myocardial recovery through imaging
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None