Stroke Study: Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Procedure: No aortic clamping; Procedure: partial occluding clamp; Procedure: cross clamp and partial occluding clamp; Procedure: single cross clamp

• Registration Number: NCT01502683
• Lead Sponsor: Emory University

Brief Summary

One of the most devastating complications of coronary artery bypass surgery (CABG) is postoperative stroke. While there are multiple causes of stroke after CABG, particles generated during handling of the aorta is believed to account for most neurologic effects. Handling of the aorta during CABG occurs several times during the operation. One strategy to reduce aortic handling is to avoid cardiopulmonary bypass altogether by using off-pump techniques (OPCAB). Another method is to avoid the use of aortic clamps and/or to use devices that do not require aortic clamping. This study will test the hypothesis that an off-pump (OPCAB) approach and devices to perform clampless surgery will result in the least amount of aortic handling and therefore the lowest incidence and frequency of neurologic adverse events.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-28
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2012-01-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

• > 18 years
• undergoing primary isolated coronary artery bypass surgery
• ability to sign informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Off-pump No Clamp	No aortic clamping	Off-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses.
Off-pump Partial Occluding Clamp	partial occluding clamp	Off-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses.
On-pump Double Clamp	cross clamp and partial occluding 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.
On-pump Single Cross Clamp	single cross clamp	On-pump coronary artery bypass patients randomized to single cross clamp for cardioplegic arrest and proximal anastomoses.

Primary Outcome Measures

Name	Time	Method
Cerebral embolic events measured via transcranial doppler ultrasound	Intraoperative cerebral embolic events	Cerebral embolic events measured via transcranial doppler ultrasound

Secondary Outcome Measures

Name	Time	Method
Neurocognitive dysfunction	30 days

Trial Locations

Locations (1)

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States