Intraoperative Epiaortic Scanning for Preventing Early St... | NCT01764763

Studies
Intraoperative Epiaortic Scanning for Preventing Early Stroke After Off-pump Coronary Artery Bypass

NCT01764763

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 10, 2013Estimated

Enrollment

2,292Actual

Phase

Not provided

Conditions

Coronary Artery Occlusive Disease

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jan 3, 2013

First Submission Date that Met QC Criteria

Jan 7, 2013

First Posted Date

Jan 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2013

Last Update Posted Date

Jan 10, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,292Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non epiaortic group		non epiaortic group ( n=1019)
epiaortic group		epiaortic group ( n=1273)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early Stroke After Off-pump Coronary Artery Bypass		number of incidence of early strok from surgery to discharge, an expected average of 5 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

31 Years

Maximum Age

88 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample