- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01840969
Association of Carotid Arterial Circumferential Strain With Left Ventricular Function and Hemodynamic Compromise During Off-pump Coronary Artery Bypass Surgery
April 25, 2013 updated by: Yonsei University
This study is aimed to evaluate the association of common carotid artery circumferential strain with the echocardiographic parameters of left ventricular function and the degree of actual hemodynamic deterioration in patients undergoing multi-vessel off-pump coronary artery bypass with preserved left ventricular ejection fraction.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 120-752
- Yonsei University College of Medicine
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for elective multivessel off-pump coronary artery bypass surgery
Description
Inclusion Criteria:
- three vessel coronary artery disease
- sinus rhythm
Exclusion Criteria:
- New York Heart Association functional class ≥3
- known pulmonary hypertension
- known valvular heart disease
- serum creatinine ≥2.0 mg/dL
- myocardial infarction within 1 week before the surgery
- history of cerebral or peripheral arterial occlusive disease
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
Cohorts and Interventions
Group / Cohort |
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CAOD group
Single arm study group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TTE parameters
Time Frame: 1 day before the surgery
|
TTE parameters: left ventricular ejection fraction, left atrial volume index, left ventricular mass, Sm, Em, E/Em
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1 day before the surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of intraoperative hemodynamic variables
Time Frame: from after induction of anesthesia, left circumflex artery grafting, and to sternum closure
|
TTE parameters: left ventricular ejection fraction, left atrial volume index, left ventricular mass, Sm, Em, E/Em Carotid circumferential strain : Storage of transverse image of the right CCA at approximately 1cm proximal to the bifurcation, manual trace of luminal-intimal border and automatic tracking by frame-to-frame movement of ultrasound reflections (speckles) Hemodynamic variables: cardiac index and mixed venous oxygen saturation obtained from the pulmonary artery catheter and cardiac output monitoring devices
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from after induction of anesthesia, left circumflex artery grafting, and to sternum closure
|
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
September 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
April 10, 2013
First Submitted That Met QC Criteria
April 25, 2013
First Posted (Estimate)
April 26, 2013
Study Record Updates
Last Update Posted (Estimate)
April 26, 2013
Last Update Submitted That Met QC Criteria
April 25, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2011-0467
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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