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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01502683
First Posted: January 2, 2012
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Halkos, Emory University
December 28, 2011
January 2, 2012
January 24, 2017
December 2011
December 2016   (Final data collection date for primary outcome measure)
Cerebral embolic events measured via transcranial doppler ultrasound [ Time Frame: Intraoperative cerebral embolic events ]
Cerebral embolic events measured via transcranial doppler ultrasound
Same as current
Complete list of historical versions of study NCT01502683 on ClinicalTrials.gov Archive Site
Neurocognitive dysfunction [ Time Frame: 30 days ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Stroke
  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: Off-pump No Clamp
    Off-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses.
    Intervention: Procedure: No aortic clamping
  • Experimental: Off-pump Partial Occluding Clamp
    Off-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses.
    Intervention: Procedure: partial occluding clamp
  • Experimental: On-pump Single Cross Clamp
    On-pump coronary artery bypass patients randomized to single cross clamp for cardioplegic arrest and proximal anastomoses.
    Intervention: Procedure: single cross clamp
  • 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.
    Intervention: Procedure: cross clamp and partial occluding clamp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01502683
IRB00046608
1K23HL105892-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Michael Halkos, Emory University
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Michael Halkos, MD Emory University
Emory University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP