StrokeNCT01502683
Stroke Study: Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
A study testing No aortic clamping, partial occluding clamp and single cross clamp in people with Stroke, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- No aortic clamping, partial occluding clamp and single cross clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years
- undergoing primary isolated coronary artery bypass surgery
- ability to sign informed consent
Who cannot join
- history of preoperative stroke
- reoperative cardiac surgery
- salvage or emergency CABG
- known left ventricular or left atrial thrombus
- concomitant valvular or aortic surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Hospital Midtown
Atlanta, Georgia, 30308
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- No aortic clamping, partial occluding clamp, single cross clamp, cross clamp and partial occluding clamp
- Keywords
- Stroke, neurocognitive dysfunction, cerebral embolic events
- Medical subject headings
- Stroke, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No aortic clampingProcedure or surgery
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.
partial occluding clampProcedure or surgery
The partial-occluding clamp is a standardized instrument used during coronary artery bypass surgery, it is not a specific device for this study.
single cross clampProcedure or surgery
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.
cross clamp and partial occluding clampProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Off-pump No Clamp | Experimental | Off-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses. Receives: Procedure: No aortic clamping |
| Off-pump Partial Occluding Clamp | Experimental | Off-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses. Receives: 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. Receives: 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. Receives: Procedure: cross clamp and partial occluding clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral embolic events measured via transcranial doppler ultrasound
Cerebral embolic events measured via transcranial doppler ultrasound
Measured: Intraoperative cerebral embolic events
Secondary outcomes (1)
Neurocognitive dysfunction
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michael Halkos, Emory University
- Investigators
- Michael Halkos, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502683
- Sponsor's protocol ID
- IRB00046608
- Other IDs
- 1K23HL105892-01A1
- Status last verified
- Jan 2017
- First submitted
- 28 Dec 2011
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operative Strategies to Reduce Cerebral Embolic Events During Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01502683
- Acronym / sponsor ID
- IRB00046608
- Conditions
- Stroke
- Keywords
- Stroke, neurocognitive dysfunction, cerebral embolic events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 2 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Off-pump No Clamp | Experimental | Procedure: No aortic clampingOff-pump coronary artery bypass patients randomized to no clamp for proximal anastomoses. |
| Off-pump Partial Occluding Clamp | Experimental | Procedure: partial occluding clampOff-pump coronary artery bypass patients randomized to partial occluding clamp for proximal anastomoses. |
| On-pump Single Cross Clamp | Experimental | Procedure: single cross clampOn-pump coronary artery bypass patients randomized to single cross clamp for cardioplegic arrest and proximal anastomoses. |
| On-pump Double Clamp | Experimental | Procedure: cross clamp and partial occluding clampOn-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years
- undergoing primary isolated coronary artery bypass surgery
- ability to sign informed consent
Key exclusion criteria (5 listed)
- history of preoperative stroke
- reoperative cardiac surgery
- salvage or emergency CABG
- known left ventricular or left atrial thrombus
- concomitant valvular or aortic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No aortic clampingNo 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 or surgery | Off-pump No Clamp |
| partial occluding clampThe partial-occluding clamp is a standardized instrument used during coronary artery bypass surgery, it is not a specific device for this study. | Procedure or surgery | Off-pump Partial Occluding Clamp |
| single cross clampThe 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 or surgery | On-pump Single Cross Clamp |
| cross clamp and partial occluding clampBoth 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. | Procedure or surgery | On-pump Double Clamp |
Primary outcome
Cerebral embolic events measured via transcranial doppler ultrasound
Time frame: Intraoperative cerebral embolic events
Cerebral embolic events measured via transcranial doppler ultrasound
1 secondary outcome
Neurocognitive dysfunction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Halkos, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No aortic clamping, partial occluding clamp and single cross clamp in people with Stroke, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral embolic events measured via transcranial doppler ultrasound (time frame: Intraoperative cerebral embolic events). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.