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

NCT01502683 | Completed DMC

• 2 other identifiers: IRB000466081K23HL105892-01A1
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; neurocognitive dysfunction; cerebral embolic events

Outcome Measures

Primary Outcomes (1)

• Cerebral embolic events measured via transcranial doppler ultrasound

  Cerebral embolic events measured via transcranial doppler ultrasound

  Intraoperative cerebral embolic events

Secondary Outcomes (1)

• Neurocognitive dysfunction

  30 days

Study Arms (4)

Off-pump No Clamp

EXPERIMENTAL

Off-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses.

Procedure: No aortic clamping

Off-pump Partial Occluding Clamp

EXPERIMENTAL

Off-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses.

Procedure: partial occluding clamp

On-pump Single Cross Clamp

EXPERIMENTAL

On-pump coronary artery bypass patients randomized to single cross clamp for cardioplegic arrest and proximal anastomoses.

Procedure: single cross clamp

On-pump Double Clamp

EXPERIMENTAL

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

Interventions

No aortic clamping PROCEDURE

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.

Off-pump No Clamp

partial occluding clamp PROCEDURE

The partial-occluding clamp is a standardized instrument used during coronary artery bypass surgery, it is not a specific device for this study.

Off-pump Partial Occluding Clamp

single cross clamp PROCEDURE

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.

On-pump Single Cross Clamp

cross clamp and partial occluding clamp PROCEDURE

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.

On-pump Double Clamp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• history of preoperative stroke
• reoperative cardiac surgery
• salvage or emergency CABG
• known left ventricular or left atrial thrombus
• concomitant valvular or aortic surgery

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Stroke; Cognition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michael Halkos, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 2, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)