Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-27 @ 11:17 AM
Study NCT ID:
NCT02587494
Status:
UNKNOWN
Last Update Posted:
2017-08-23
First Post:
2015-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Catheterization in Cardiac Arrest
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Role of Early Cardiac Catheterization in Cardiac Arrest
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.
Detailed Description:
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
Study Oversight
Has Oversight DMC:
False
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?: