Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294814
Status:
UNKNOWN
Last Update Posted:
2007-03-20
First Post:
2006-02-20
Brief Title:
TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting CABG The Influence of Proximal Anastomosis Technique
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Gas and Solid Brain Microembolization Detected by the EmbodopR TCD System During Proximal Coronary Graft Anastomosis Done With Aortic Cross Clamping Partial Occlusion or the HeartstringR Device and Their Effect on Neurocognitive Performance After Coronary Bypass Operation
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
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:
The purpose of this study is to test the hypothesis that using three different techniques to anastomose coronary grafts to the aorta partial occlusion single cross clamp or using the Heartstring anastomotic device will change the amount of gas and solid microemboli as detected by the EmbodopR transcranial Doppler TCD system and consequently the neurocognitive performance of patients after coronary bypass operation
Detailed Description:
It is not uncommon for a cardiac surgical patient to have his heart fixed but his brain damaged Sometimes the damage is overt and manifests itself as a major neurological deficiency The frequency of stroke the so called type 1 damage is reported to be between 1 and 4 percent This may increase mortality from 14 to 22 and hospitalization from 66 days to 175 days Diffuse encephalopathy presenting as delirium confusion coma and seizures so called type 2 damage is reported to appear in a much higher frequency of 3 to 7 depending on timing and methods of evaluation This type of damage will increase mortality from 14 to 75 and hospitalization from 66 to 152 Sometimes it is more subtle and appears as neurocognitive decline This type of damage may be found in 53 of the patients at discharge in 24 after six months and the frequency rises again to 42 at five years The impact on the patient and his family might be devastating and the burden on the medical system and society enormous Long term moderate to severe disability may affect 69 of the stroke patients and survival may decline to 67 after one year
After years of research efforts it became evident that inadequate global blood flow to the brain is relatively uncommon and cerebral hemorrhage is a rare cause of brain damage during cardiac operations It also became evident that one of the most important damage mechanisms is embolization to the brain and the inflammatory response which amplifies the ischemic embolic damage Looking for possible embolic sources by monitoring embolic signals HITS on the transcranial doppler TCD tracings researchers found that manipulation of the aorta during cardiac surgery like cannulation and especially clamping is a major source of emboli Using the side biting clamp while performing proximal anastomosis has the potential to crush the aortic wall and release macro and micro emboli especially when the aorta is atherosclerotic Using a single cross clamp technique might eliminate the aortic wall solid debris but introduce air emboli instead
Dealing with the same problem a few proximal anastomotic devices have been introduced and most of them withdrawn from the market because of inferior patency rate The Heartstring proximal anastomotic device is one of the recently introduced devices for which early good patency rate has been demonstrated The advantages in terms of less brain embolization or improved neurologic outcome have never been demonstrated for the Heartstring or any other anastomotic device
A recent potential breakthrough in this field of emboli research and prevention in order to improve neurologic outcome after cardiac surgery is the introduction of the EmbodopR system by DWL This is a high quality TCD system which has been further developed to monitor cerebral emboli It contains a module which automatically screens every event suspected as embolic eliminates those recognized as artifacts according to four different criteria and records only real embolic events Another module can differentiate every event as gas or solid emboli by simultaneously insonating the middle cerebral artery blood with tow ultrasound beams each of different frequency The result is a new ability for real time monitoring and characterization of embolic events during cardiac operations
After years of research efforts it became evident that inadequate global blood flow to the brain is relatively uncommon and cerebral hemorrhage is a rare cause of brain damage during cardiac operations It also became evident that one of the most important damage mechanisms is embolization to the brain and the inflammatory response which amplifies the ischemic embolic damage Looking for possible embolic sources by monitoring embolic signals HITS on the transcranial doppler TCD tracings researchers found that manipulation of the aorta during cardiac surgery like cannulation and especially clamping is a major source of emboli Using the side biting clamp while performing proximal anastomosis has the potential to crush the aortic wall and release macro and micro emboli especially when the aorta is atherosclerotic Using a single cross clamp technique might eliminate the aortic wall solid debris but introduce air emboli instead
Dealing with the same problem a few proximal anastomotic devices have been introduced and most of them withdrawn from the market because of inferior patency rate The Heartstring proximal anastomotic device is one of the recently introduced devices for which early good patency rate has been demonstrated The advantages in terms of less brain embolization or improved neurologic outcome have never been demonstrated for the Heartstring or any other anastomotic device
A recent potential breakthrough in this field of emboli research and prevention in order to improve neurologic outcome after cardiac surgery is the introduction of the EmbodopR system by DWL This is a high quality TCD system which has been further developed to monitor cerebral emboli It contains a module which automatically screens every event suspected as embolic eliminates those recognized as artifacts according to four different criteria and records only real embolic events Another module can differentiate every event as gas or solid emboli by simultaneously insonating the middle cerebral artery blood with tow ultrasound beams each of different frequency The result is a new ability for real time monitoring and characterization of embolic events during cardiac operations
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