- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764763
Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass
January 7, 2013 updated by: Yonsei University
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2292
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
31 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From January 2001 to December 2011, 2292 patients who underwent isolated off-pump coronary artery bypass at Yonsei Cardiovascular Hospital in Seoul
Description
Inclusion Criteria:
patients underwent who isolated off-pump coronary artery bypass
Exclusion Criteria:
- combined carotid procedures
- preoperative cerebral haemorrhage
- nonoperative unstable vital signs such as ventricular fibrillation or cardiac arrest
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
non epiaortic group
non epiaortic group ( n=1019)
|
|
epiaortic group
epiaortic group ( n=1273)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
number of incidence of early strok from surgery to discharge, an expected average of 5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
January 3, 2013
First Submitted That Met QC Criteria
January 7, 2013
First Posted (Estimate)
January 10, 2013
Study Record Updates
Last Update Posted (Estimate)
January 10, 2013
Last Update Submitted That Met QC Criteria
January 7, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 4-2010-0868
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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