Coronary Artery AtherosclerosisPhase 3NCT01310608
Effect Study of Modified Transoesophageal Echocardiography on Cerebral Embolization After Cardiothoracic Surgery
A Phase 3 study testing A-View in people with Coronary Artery Atherosclerosis, run by Isala.
Trial summary
Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Atherosclerosis
- What is being tested?
- A-View
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Jun 2011
- Phase
- Phase 3
- 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
- Isolated CABG
- Elective surgery
- Stroke Risk Index <75(Newman, '96)
Who cannot join
- Other than isolated CABG
- Contra-indication for TEE
- Contra-indication for A-View
- Contra-indication for MRI
About this study
Official title: Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery
Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan, to reduce the risk of embolization and thus subsequent neurologic complications.
Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound scanning has become the gold standard, but is seldom used as it interferes often with surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE) is a widely used imaging method permitting evaluation of the aorta preoperatively, but assessment of distal AA is hampered by interposition of air-filled trachea between esophagus and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the A-View® have successfully been shown in previous studies. The hypothesis of this study is that the use of A-View will reduce cerebral embolization secondary to a change of surgical technique.
- Conditions
- Coronary Artery Atherosclerosis
- Being tested
- A-View
- Keywords
- Atherosclerosis aorta, A-View, Distal ascending aorta, Transoesophageal echocardiography, CABG, Cerebral embolisation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-ViewOther
Also called The A-View®, Aortic-view®, Modified transoesophageal echocardiography, FDA: 070515
Pre-operative imaging of the thoracic aorta with A-View technique
| Study group | Role | What they receive |
|---|---|---|
| A-View | Experimental | Not described Receives: Other: A-View |
| No A-View | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
New diffusion-weighted lesions on cerebral MRI
Measured: 3 - 4 Days after intervention
Secondary outcomes (8)
The number, size, and location of new ischemic lesions on the postoperative DW-MRI
Measured: 3 - 4 Days after intervention
Any neurologic event during the first six postoperative weeks, which is manifested as either stroke, or transient ischemic attack (TIA), epileptic insults, or delirium, or cognitive deficit
Measured: 6 weeks postoperative
Stroke or TIA during the first three postoperative months
Measured: 3 months postoperative
Delirium during hospital stay
Measured: Until hospital discharge
Quality of life
Measured: 6 weeks and 1 year after the intervention
Number of "HITS" detected by Transcranial Doppler
Measured: peroperive
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)
Measured: Peroperative
Short psychometric test
Measured: 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery AtherosclerosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Collaborators
- Zorgvernieuwing
- Responsible party
- Principal investigator, Arno P. Nierich, Isala
- Investigators
- Arno Nierich, MD, PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310608
- Sponsor's protocol ID
- A-View 3
- Status last verified
- Aug 2012
- First submitted
- 7 Mar 2011
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Imaging of the Ascending Aorta With Modified Transoesophageal Echocardiography on New Dw-MRI Lesions After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01310608
- Acronym / sponsor ID
- A-View 3
- Conditions
- Coronary Artery Atherosclerosis
- Keywords
- Atherosclerosis aorta, A-View, Distal ascending aorta, Transoesophageal echocardiography, CABG, Cerebral embolisation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Collaborators
- Zorgvernieuwing
- Study start
- Mar 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Mar 2011 (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.
Patients undergoing cardiac surgery frequently develop neurologic complications, ranging from subtle cognitive changes to evident confusion, delirium, and stroke. This continuum of complications is commonly caused by embolization in the brain due to manipulation of atherosclerotic parts of the aorta ascendens (AA) during surgery. Timely detection of AA atherosclerosis before surgery enables the surgeon to consider changes of the surgical plan, to reduce the risk of embolization and thus subsequent neurologic complications.
Various methods exist to visualize the AA to detect atherosclerosis. Epiaortic ultrasound scanning has become the gold standard, but is seldom used as it interferes often with surgical plan and can only be used after sternotomy. Transesophageal echocardiography (TEE) is a widely used imaging method permitting evaluation of the aorta preoperatively, but assessment of distal AA is hampered by interposition of air-filled trachea between esophagus and AA. The A-View® (Aortic-view) method, a modification of conventional TEE using a fluidfilled balloon, overcomes this limitation. The safety and diagnostic accuracy of the A-View® have successfully been shown in previous studies. The hypothesis of this study is that the use of A-View will reduce cerebral embolization secondary to a change of surgical technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-View | Experimental | Other: A-View |
| No A-View | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated CABG
- Elective surgery
- Stroke Risk Index <75(Newman, '96)
Key exclusion criteria (4 listed)
- Other than isolated CABG
- Contra-indication for TEE
- Contra-indication for A-View
- Contra-indication for MRI
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 |
|---|---|---|
| A-ViewAlso: The A-View®, Aortic-view®, Modified transoesophageal echocardiography, FDA: 070515Pre-operative imaging of the thoracic aorta with A-View technique | Other | A-View |
Primary outcome
New diffusion-weighted lesions on cerebral MRI
Time frame: 3 - 4 Days after intervention
8 secondary outcomes
The number, size, and location of new ischemic lesions on the postoperative DW-MRI
Time frame: 3 - 4 Days after intervention
Any neurologic event during the first six postoperative weeks, which is manifested as either stroke, or transient ischemic attack (TIA), epileptic insults, or delirium, or cognitive deficit
Time frame: 6 weeks postoperative
Stroke or TIA during the first three postoperative months
Time frame: 3 months postoperative
Delirium during hospital stay
Time frame: Until hospital discharge
Quality of life
Time frame: 6 weeks and 1 year after the intervention
Number of "HITS" detected by Transcranial Doppler
Time frame: peroperive
Incidence of Near Infrared Spectrography desaturations (NIRO 2000)
Time frame: Peroperative
Short psychometric test
Time frame: 6 weeks after intervention
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 9 Aug 2012.
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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.
Arno Nierich, MD, PhD principal investigator
Isala
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A-View in people with Coronary Artery Atherosclerosis, run by Isala.
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 4 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
New diffusion-weighted lesions on cerebral MRI (time frame: 3 - 4 Days after intervention). 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 9 Aug 2012.