Clinical trial NCT01502683: Stroke Study: Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
Official title: Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
neurocognitive dysfunction
cerebral embolic events
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-01-02
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cerebral embolic events measured via transcranial doppler ultrasound
timeFrame: Intraoperative cerebral embolic events
Secondary outcomes:
measure: Neurocognitive dysfunction
timeFrame: 30 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Halkos, MD
role: PRINCIPAL_INVESTIGATOR
References: