Three Vessel Coronary Artery DiseaseNCT01840969
Association of Carotid Arterial Circumferential Strain With Left Ventricular Function and Hemodynamic Compromise During Off-pump Coronary Artery Bypass Surgery
An observational study of Three Vessel Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Three Vessel Coronary Artery Disease
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Feb 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective multivessel off-pump coronary artery bypass surgery
Who may be able to join
- three vessel coronary artery disease
- sinus rhythm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
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.
- Conditions
- Three Vessel Coronary Artery Disease
- Keywords
- off-pump coronary artery bypass surgery, common carotid artery, speckle tracking analysis, peak strain
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 |
|---|---|---|
| CAOD group | Single arm study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
TTE parameters
TTE parameters: left ventricular ejection fraction, left atrial volume index, left ventricular mass, Sm, Em, E/Em
Measured: 1 day before the surgery
Secondary outcomes (1)
change of intraoperative hemodynamic variables
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
Measured: from after induction of anesthesia, left circumflex artery grafting, and to sternum closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startSep 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three Vessel Coronary Artery 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 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
- NCT01840969
- Sponsor's protocol ID
- 4-2011-0467
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Carotid Arterial Circumferential Strain With Left Ventricular Function and Hemodynamic Compromise During Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01840969
- Acronym / sponsor ID
- 4-2011-0467
- Conditions
- Three Vessel Coronary Artery Disease
- Keywords
- off-pump coronary artery bypass surgery, common carotid artery, speckle tracking analysis, peak strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Apr 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAOD group | – | –Single arm study group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective multivessel off-pump coronary artery bypass surgery
Key inclusion criteria (2 listed)
- three vessel coronary artery disease
- sinus rhythm
Key exclusion criteria (6 listed)
- 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
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
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
1 secondary outcome
change of intraoperative hemodynamic variables
Time frame: from after induction of anesthesia, left circumflex artery grafting, and to sternum closure
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 26 Apr 2013.
Related trials for Three Vessel Coronary Artery Disease
RecruitingObservational study
Insights From the FAST-TRACK CABG Trial: a Clinical Outcome Study in Patient With Previous Surgical Revascularization for Complex Three-vessel or Left Main Coronary Artery Disease Based on Coronary Computed Tomography Angiogram, and Fractional Flow Reserve Derived by Computed Tomography
Multivessel Coronary Artery Disease
Recruiting
Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease
Coronary Artery Stenosis
Active, not recruitingPhase 4
Evolocumab or Normal Strategies to Reach LDL Objectives in Acute Myocardial Infarction Upbound to PCI
STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
Active, not recruiting
Multivessel TALENT
Coronary Artery Disease, Myocardial Ischemia
RecruitingObservational study
Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients With Coronary Artery Disease
Coronary Artery Disease (CAD)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Three Vessel Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 6 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 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
TTE parameters (time frame: 1 day before the surgery). 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 26 Apr 2013.