Stroke Study: Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
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|ClinicalTrials.gov Identifier: NCT01502683|
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : January 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Procedure: No aortic clamping Procedure: partial occluding clamp Procedure: single cross clamp Procedure: cross clamp and partial occluding clamp||Not Applicable|
One of the most devastating complications of coronary artery bypass surgery (CABG) is postoperative stroke. While the etiology of stroke after CABG is multifactorial, atheroemboli generated during aortic manipulation is believed to account for most cerebral embolic events. Manipulation of the aorta during CABG occurs during aortic cannulation, institution and maintenance of cardiopulmonary bypass, and during aortic clamping and unclamping with either a cross-clamp, partial-occluding clamp, or both. One operative strategy to minimize aortic manipulation is to avoid cardiopulmonary bypass altogether by using off-pump techniques (OPCAB). Another method is to avoid the use of aortic clamps and to construct proximal aortocoronary anastomoses with facilitating devices that do not require aortic clamping. The effect of these strategies on reducing cerebral embolic events and the underlying mechanism for this reduction are not well-defined.
This study will test the hypothesis that an off-pump (OPCAB) approach and facilitating devices to perform clampless proximal anastomoses will result in the least amount of aortic manipulation and therefore the lowest incidence and frequency of cerebral embolic events. The approach associated with the lowest incidence of TCD-detected cerebral embolic events will also result in the lowest incidence and severity of postoperative neurocognitive decline. Transcranial Doppler ultrasonography is an established method to detect cerebral embolic signals during cardiac surgery and will be utilized to detect cerebral embolic events during the operation. After an on- or off-pump strategy is selected, patients will be subsequently randomized to one of two clamping strategies. There will be 4 groups of patients: 1) OPCAB patients randomized to no clamping (facilitating device); 2) OPCAB patients randomized to partial clamping; 3) on-pump patients randomized to double clamping; and 4) on-pump patients randomized to a single clamp strategy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||193 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Off-pump No Clamp
Off-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses.
Procedure: No aortic clamping
No aortic clamp used in this group. The aortic clamp is a standard cardiac surgical instrument used during cardiac operations, not a specific device used for this study.
Experimental: Off-pump Partial Occluding Clamp
Off-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses.
Procedure: partial occluding clamp
The partial-occluding clamp is a standardized instrument used during coronary artery bypass surgery, it is not a specific device for this study.
Experimental: On-pump Single Cross Clamp
On-pump coronary artery bypass patients randomized to single cross clamp for cardioplegic arrest and proximal anastomoses.
Procedure: single cross clamp
The proximal anastomoses performed under single clamp is an alternative method during coronary artery bypass surgery. The single clamp essentially means that whole operation is done using the cross clamp, which is a standard instrument during cardiac operations, not a specific device for this study.
Experimental: On-pump Double Clamp
On-pump coronary artery bypass patients randomized to cross-clamp for cardioplegic arrest and partial-occluding clamp for proximal anastomoses. This strategy involves the application of two clamps.
Procedure: cross clamp and partial occluding clamp
Both an aortic cross clamp and partial occluding clamp are used in this arm. Neither the cross clamp nor the partial clamp are specific devices for this study but are standard cardiac surgical instruments used during coronary artery bypass surgery and cardiac surgery.
- Cerebral embolic events measured via transcranial doppler ultrasound [ Time Frame: Intraoperative cerebral embolic events ]Cerebral embolic events measured via transcranial doppler ultrasound
- Neurocognitive dysfunction [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502683
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Principal Investigator:||Michael Halkos, MD||Emory University|