- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502683
Stroke Study: Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- > 18 years
- undergoing primary isolated coronary artery bypass surgery
- ability to sign informed consent
Exclusion Criteria:
- history of preoperative stroke
- reoperative cardiac surgery
- salvage or emergency CABG
- known left ventricular or left atrial thrombus
- concomitant valvular or aortic surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Off-pump No Clamp
Off-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses.
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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.
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Experimental: Off-pump Partial Occluding Clamp
Off-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses.
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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.
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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.
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral embolic events measured via transcranial doppler ultrasound
Time Frame: Intraoperative cerebral embolic events
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Cerebral embolic events measured via transcranial doppler ultrasound
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Intraoperative cerebral embolic events
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neurocognitive dysfunction
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00046608
- 1K23HL105892-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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