Coronary Artery DiseaseStrainNCT02692131
Comparison of Two Methods of Strain by Perioperative Transesophageal Echo in CABG : An Observational Study
An observational study of Coronary Artery Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
There is an increasing need for diagnostic modalities able to objectively quantify myocardial function. Quantification of regional myocardial function with ultrasound is challenging on its own. Visual assessment of wall motion and thickening requires extensive training [1] and remains highly subjective [2]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2016to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult (> 18 yrs) patients undergoing on pump CABG.
Who may be able to join
- > 18 yrs
- On pump CABG
Who cannot join
- < 18 yrs
- other on pump cardiac surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Methods of Obtaining Strain by Perioperative Transesophageal in Patients Undergoing Coronary Artery Bypass Grafting : An Observational Study
There is an increasing need for diagnostic modalities able to objectively quantify myocardial function. Quantification of regional myocardial function with ultrasound is challenging on its own. Visual assessment of wall motion and thickening requires extensive training [1] and remains highly subjective [2]. Tissue deformation imaging is a recently introduced technique which enables the objective assessment of regional myocardial deformation assessed by ultrasound based strain and strain rate using Doppler Tissue Imaging or Speckle tracking. There are limited number of studies comparing the myocardial deformation parameters (i.e. Strain and Strain rate) by 2 different echocardiographic techniques viz Doppler tissue imaging and Speckle tracking in the perioperative period. In this study, we plan to study the above said parameters in patients undergoing coronary artery bypass grafting using transesophageal echocardiography and correlate these parameters with cardiac output by thermodilution method using pulmonary artery catheter.
Read the detailed description
The study will be conducted in the Department of Anaesthesiology and Intensive Care, Advanced Cardiac Centre, Post Graduate Institute Medical Education Research, Chandigarh after obtaining institutional ethical committee clearance. Fifty patients scheduled for coronary artery bypass grafting (CABG) will be included in the study. An informed written consent will be taken from all the patients.
Anaesthesia technique All patients will be examined a day prior to surgery. Baseline data including preoperative physical status, haemogram, biochemistry, preoperative transthoracic echocardiography and coronary angiography data will be noted. A standard anaesthesia technique will be used for all the patients. Inside the operating room, electrocardiography (ECG), pulse oximetry and noninvasive blood pressure (NIBP) will be applied. Anaesthesia will be induced with fentanyl 5 - 10 µg/kg/ body weight and propofol titrated to loss of response to verbal commands followed by endotracheal intubation facilitated by vecuronium 0.1mg/kg. A 20 gauge arterial catheter will be inserted in left radial artery and right internal jugular vein will be cannulated with triple lumen catheter for central venous access and pulmonary artery catheter for haemodynamic assessment. A baseline transthoracic echocardiogram will be performed after induction of general anaesthesia. After induction of general anaesthesia , a TEE probe (GE Medical Systems, Horten, Norway) will be introduced. Anaesthesia will be maintained by isoflurane, intravenous morphine (intermittent boluses; total 0.5 mg/kg during surgery) and vecuronium boluses. All patients will undergo CABG under cardiopulmonary bypass (CPB) support. Total cardiopulmonary bypass time and Aortic cross clamp time will be noted. Patients will be shifted to cardiac surgical intensive care unit (ICU) and electively ventilated. Decision on extubation and inotrope support will be left to attending intensivist.
Echocardiography data After induction of general anaesthesia, a comprehensive transesophageal echocardiogram will be performed using probe of the GE vivid E9 echocardiography system (GE Medical Systems, Hortein, Norway) in all the patients.
The following parameters will be noted before instituting CPB and after weaning from CPB and achievement of stable haemodynamics:
- 2 dimensional Left ventricular ejection fraction using Simpson's method from midesophageal 4 chamber and midesophageal 2 chamber views.
- 3 dimensional Left ventricular ejection fraction from midesophageal 4 chamber and midesophageal 2 chamber views.
- Doppler tissue imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.
- Speckle track imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.
An average of 3 readings over 3 different cardiac cycles will be used for above parameters.
- Conditions
- Coronary Artery Disease
- Keywords
- Left Ventricle strain, speckle strain
- Medical subject headings
- Coronary Artery 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 |
|---|---|---|
| Speckle strain | All adult patients undergoing on pump CABG Surgery. | |
| Tissue doppler strain | All adult patients undergoing on pump CABG Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between left ventricle strain measured by Doppler tissue imaging and speckle tracking using transesophageal echocardiography in patients undergoing coronary artery bypass surgery.
Measured: Intraoperatively before going on bypass and 30 mins after coming off bypass.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Alok Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Banashree mandal, MD, DM, Study chair, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692131
- Sponsor's protocol ID
- NK/2496/study
- Acronym
- Strain
- Status last verified
- Sep 2016
- First submitted
- 16 Feb 2016
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Methods of Obtaining Strain by Perioperative Transesophageal in Patients Undergoing Coronary Artery Bypass Grafting : An Observational Study
- ClinicalTrials.gov ID
- NCT02692131
- Acronym / sponsor ID
- Strain / NK/2496/study
- Conditions
- Coronary Artery Disease
- Keywords
- Left Ventricle strain, speckle strain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Feb 2016 (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.
There is an increasing need for diagnostic modalities able to objectively quantify myocardial function. Quantification of regional myocardial function with ultrasound is challenging on its own. Visual assessment of wall motion and thickening requires extensive training [1] and remains highly subjective [2]. Tissue deformation imaging is a recently introduced technique which enables the objective assessment of regional myocardial deformation assessed by ultrasound based strain and strain rate using Doppler Tissue Imaging or Speckle tracking. There are limited number of studies comparing the myocardial deformation parameters (i.e. Strain and Strain rate) by 2 different echocardiographic techniques viz Doppler tissue imaging and Speckle tracking in the perioperative period. In this study, we plan to study the above said parameters in patients undergoing coronary artery bypass grafting using transesophageal echocardiography and correlate these parameters with cardiac output by thermodilution method using pulmonary artery catheter.
Detailed description
The study will be conducted in the Department of Anaesthesiology and Intensive Care, Advanced Cardiac Centre, Post Graduate Institute Medical Education Research, Chandigarh after obtaining institutional ethical committee clearance. Fifty patients scheduled for coronary artery bypass grafting (CABG) will be included in the study. An informed written consent will be taken from all the patients.
Anaesthesia technique All patients will be examined a day prior to surgery. Baseline data including preoperative physical status, haemogram, biochemistry, preoperative transthoracic echocardiography and coronary angiography data will be noted. A standard anaesthesia technique will be used for all the patients. Inside the operating room, electrocardiography (ECG), pulse oximetry and noninvasive blood pressure (NIBP) will be applied. Anaesthesia will be induced with fentanyl 5 - 10 µg/kg/ body weight and propofol titrated to loss of response to verbal commands followed by endotracheal intubation facilitated by vecuronium 0.1mg/kg. A 20 gauge arterial catheter will be inserted in left radial artery and right internal jugular vein will be cannulated with triple lumen catheter for central venous access and pulmonary artery catheter for haemodynamic assessment. A baseline transthoracic echocardiogram will be performed after induction of general anaesthesia. After induction of general anaesthesia , a TEE probe (GE Medical Systems, Horten, Norway) will be introduced. Anaesthesia will be maintained by isoflurane, intravenous morphine (intermittent boluses; total 0.5 mg/kg during surgery) and vecuronium boluses. All patients will undergo CABG under cardiopulmonary bypass (CPB) support. Total cardiopulmonary bypass time and Aortic cross clamp time will be noted. Patients will be shifted to cardiac surgical intensive care unit (ICU) and electively ventilated. Decision on extubation and inotrope support will be left to attending intensivist.
Echocardiography data After induction of general anaesthesia, a comprehensive transesophageal echocardiogram will be performed using probe of the GE vivid E9 echocardiography system (GE Medical Systems, Hortein, Norway) in all the patients.
The following parameters will be noted before instituting CPB and after weaning from CPB and achievement of stable haemodynamics:
- 2 dimensional Left ventricular ejection fraction using Simpson's method from midesophageal 4 chamber and midesophageal 2 chamber views.
- 3 dimensional Left ventricular ejection fraction from midesophageal 4 chamber and midesophageal 2 chamber views.
- Doppler tissue imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.
- Speckle track imaging derived regional and global longitudinal strain from midesophageal 4 chamber, midesophageal 2 chamber and midesophageal long axis views.
An average of 3 readings over 3 different cardiac cycles will be used for above parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speckle strain | – | –All adult patients undergoing on pump CABG Surgery. |
| Tissue doppler strain | – | –All adult patients undergoing on pump CABG Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (> 18 yrs) patients undergoing on pump CABG.
Key inclusion criteria (2 listed)
- > 18 yrs
- On pump CABG
Key exclusion criteria (2 listed)
- < 18 yrs
- other on pump cardiac 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
Correlation between left ventricle strain measured by Doppler tissue imaging and speckle tracking using transesophageal echocardiography in patients undergoing coronary artery bypass surgery.
Time frame: Intraoperatively before going on bypass and 30 mins after coming off bypass.
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 28 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Banashree mandal, MD, DM study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
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 Coronary Artery Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 2 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 28 Sep 2016. 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 India. 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?
Correlation between left ventricle strain measured by Doppler tissue imaging and speckle tracking using transesophageal echocardiography in patients undergoing coronary artery bypass surgery. (time frame: Intraoperatively before going on bypass and 30 mins after coming off bypass.). 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 28 Sep 2016.