Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189215
Status:
COMPLETED
Last Update Posted:
2007-12-04
First Post:
2005-09-13
Brief Title:
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting is Off-Pump Surgery Beneficial
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting is Off-Pump Surgery Beneficial
Status:
COMPLETED
Status Verified Date:
2005-03
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:
None
Brief Summary:
Coronary artery bypass surgery is associated with postoperative cognitive decline which has largely been attributed to the use of the heart lung machine We hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine The objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome five years after surgery
Detailed Description:
Background
Coronary artery bypass surgery is associated with postoperative cognitive decline which has largely been attributed to the use of cardiopulmonary bypass CPB A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24 at six months after surgery but it increased to 42 at five years In the recently conducted Octopus Randomized Trial cognitive decline at three months after surgery was present in 29 of the patients operated with CPB In the patients operated without CPB the incidence was 21 ie only slightly better
Hypothesis
Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery compared to three months after surgery
Study objectives
The objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome five years after surgery
Methods
The 281 participants of the Octopus Study who were operated on between March 1998 and August 2000 and randomized to off-pump or on-pump coronary bypass surgery will be invited for an additional assessment of their cognitive and clinical status and quality of life five years after surgery Patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status Clinical status will be assessed by an interview Questionnaires will be used to measure quality of life
Coronary artery bypass surgery is associated with postoperative cognitive decline which has largely been attributed to the use of cardiopulmonary bypass CPB A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24 at six months after surgery but it increased to 42 at five years In the recently conducted Octopus Randomized Trial cognitive decline at three months after surgery was present in 29 of the patients operated with CPB In the patients operated without CPB the incidence was 21 ie only slightly better
Hypothesis
Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery compared to three months after surgery
Study objectives
The objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome five years after surgery
Methods
The 281 participants of the Octopus Study who were operated on between March 1998 and August 2000 and randomized to off-pump or on-pump coronary bypass surgery will be invited for an additional assessment of their cognitive and clinical status and quality of life five years after surgery Patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status Clinical status will be assessed by an interview Questionnaires will be used to measure quality of life
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?:
None