Ignite Creation Date:
2025-12-18 @ 9:42 AM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT04387513
Status:
None
Last Update Posted:
2020-05-19 00:00:00
First Post:
2020-05-10 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Early Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Retrospective Study
Sponsor:
None
Organization:
Study Overview
Official Title:
Impact of Cardiac Surgery in Severe Left Endocarditis With Neurological Complications: a Multicentric,Retrospective, Propensity-score Matching Study
Status:
None
Status Verified Date:
2020-05
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:
ICE-COCA
Brief Summary:
Surgical delay in severe endocardits, with neurological complications, is still debated. Early surgery, if indicated, permits to avoid new embolic events, or to fix valvular damages, but can create or increase a cerebral hemorrage.
Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.
Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.
Primary endpoint:
1\) Mortality at 1 year
Secondary endpoints:
1. Analyze the factors associated with neurological degradation
2. Evaluate the neurological tolerance of cardiac surgery.
Methods Multicentric study (7 French university hospitals). Retrospective study: from august 2010 to december 2017. Propensity score matching study. 192 patients are included.
Hypothesis Cardiac surgery, as soon as possible, if indicated, would reduce mortality, in severe left endocarditis, with neurological complications.
Primary objective To assess the impact of early versus late cardiac surgery on mortality at 1 year, in patients with severe endocarditis, with neurological complications.
Primary endpoint:
1\) Mortality at 1 year
Secondary endpoints:
1. Analyze the factors associated with neurological degradation
2. Evaluate the neurological tolerance of cardiac surgery.
Methods Multicentric study (7 French university hospitals). Retrospective study: from august 2010 to december 2017. Propensity score matching study. 192 patients are included.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: