Coronary Artery Occlusive DiseaseNCT01764763
Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass
An observational study of Coronary Artery Occlusive Disease, run by Yonsei University.
Trial summary
Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool to accurately assess ascending aorta disease. To date, several studies have reported that EAS is superior to TEE and surgical palpation Read more about this study
- Who is it for?
- Ages 31 to 88 years
- Conditions the study is for
- Coronary Artery Occlusive Disease
- How many people
- 2,292 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Mar 2011
- Phase
- Observational
- 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 31 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From January 2001 to December 2011, 2292 patients who underwent isolated off-pump coronary artery bypass at Yonsei Cardiovascular Hospital in Seoul
Who may be able to join
- patients underwent who isolated off-pump coronary artery bypass
Who cannot join
- combined carotid procedures
- preoperative cerebral haemorrhage
- nonoperative unstable vital signs such as ventricular fibrillation or cardiac arrest
About this study
Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool to accurately assess ascending aorta disease. To date, several studies have reported that EAS is superior to TEE and surgical palpation
- Conditions
- Coronary Artery Occlusive Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non epiaortic group | non epiaortic group ( n=1019) | |
| epiaortic group | epiaortic group ( n=1273) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Stroke After Off-pump Coronary Artery Bypass
Measured: number of incidence of early strok from surgery to discharge, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764763
- Sponsor's protocol ID
- 4-2010-0868
- Status last verified
- Jan 2013
- First submitted
- 3 Jan 2013
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT01764763
- Acronym / sponsor ID
- 4-2010-0868
- Conditions
- Coronary Artery Occlusive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,292 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jan 2013 (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.
Recently epiaortic ultrasound scanning (EAS) has been recommended as an intraoperative tool to accurately assess ascending aorta disease. To date, several studies have reported that EAS is superior to TEE and surgical palpation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non epiaortic group | – | –non epiaortic group ( n=1019) |
| epiaortic group | – | –epiaortic group ( n=1273) |
Who may qualify
- Ages
- 31 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2001 to December 2011, 2292 patients who underwent isolated off-pump coronary artery bypass at Yonsei Cardiovascular Hospital in Seoul
Key inclusion criteria (1 listed)
- patients underwent who isolated off-pump coronary artery bypass
Key exclusion criteria (3 listed)
- combined carotid procedures
- preoperative cerebral haemorrhage
- nonoperative unstable vital signs such as ventricular fibrillation or cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early Stroke After Off-pump Coronary Artery Bypass
Time frame: number of incidence of early strok from surgery to discharge, an expected average of 5 weeks
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 10 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Occlusive Disease, run by Yonsei University.
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 1 inclusion and 3 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 10 Jan 2013. 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.
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?
Early Stroke After Off-pump Coronary Artery Bypass (time frame: number of incidence of early strok from surgery to discharge, an expected average of 5 weeks). 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 10 Jan 2013.