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Validation of Strain and Strain Rate: a pilot study comparing transthoracic and transoesophageal echocardiography in patients undergoing coronary artery bypass grafting


- candidate number19529
- NTR NumberNTR4802
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2014
- Secondary IDsMETc 2013/404 Strain 001
- Public TitleValidation of Strain and Strain Rate: a pilot study comparing transthoracic and transoesophageal echocardiography in patients undergoing coronary artery bypass grafting
- Scientific TitleValidation of Strain and Strain Rate: a pilot study comparing transthoracic and transoesophageal echocardiography in patients undergoing coronary artery bypass grafting
- ACRONYM
- hypothesisThe primary endpoint of this study is to assess if myocardial strain and strain rate -measured with tissue Doppler and 2D speckle tracking- determined with TOE is comparable with cardiac strain and strain rate determined with TTE.
Secondary endpoint is to validate echocardiographic systolic and diastolic parameters comparing values obtained with TTE with those obtained with TOE.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG)
- Inclusion criteria1. patients older than 18 years
2. patients who can give informed consent
3. ejection fraction (EF) > 50%
4. patients referred for elective and in-house OPCAB
- Exclusion criteria1. patients who are unable to give consent
2. patients < 18 years
3. patients who are already part of another randomized study
4. emergency OPCAB
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2014
- planned closingdate31-dec-2015
- Target number of participants40
- InterventionsThere will be no medical intervention based on the data obtained with the study.
- Primary outcomeThe main endpoint of this study is to compare values of strain and strain rate measured with TOE and TTE.
- Secondary outcomeThe secondary endpoint of this study is to compare systolic and diastolic values measured with TOE and TEE
- TimepointsPre operative
Perioperative
Post operative
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES R. Spanjersberg
- CONTACT for SCIENTIFIC QUERIES M. Modestini
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryThis is an observational prospective pilot study comparing myocardial strain values obtained with both TTE and TOE, involving patients undergoing off pump CABG (OPCAB).
Forty patients undergoing OPCAB will be included in this study. Beside standard clinical practice a transthoracic echocardiography will be performed three times perioperatively, i.e. before induction of anesthesia, before start of surgery, at the end of surgery. TTE data will be compared with TOE data to assess validity of the latter. Near infrared spectroscopy electrodes will be applied on the thorax of the patient, above the heart, outside the surgical field. Data of regional tissue oxygenation will be compared with echocardiographic data. Patients undergoing this study will not incur any extra risk, beside those from the operation itself
- Main changes (audit trail)
- RECORD22-sep-2014 - 15-okt-2014


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