Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device
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|ClinicalTrials.gov Identifier: NCT02919124|
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : January 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis||Device: Echoclip||Not Applicable|
The technical quality of coronary artery bypass anastomoses during coronary artery bypass grafting is often evaluated by measuring flow rate in grafts using transit time flowmetry. Unfortunately, flow rate and flow waveform are poor indicators of the anatomy of anastomoses. A better way to evaluate the anatomy of an anastomosis is 3-dimensional imaging. Three problems must be overcome in performing epicardial echocardiography on the beating heart:
- The transducer must be kept in a steady position relative to the anastomosis for 5 to 10 cardiac cycles to minimize frame-rate variability.
- Ultrasound gel must be kept in contact with the transducer and the region studied.
- The transducer must not cause any deformation of the vessels.
The investigators designed an ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg, Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging. The present study is a feasibility study with the aim to evaluate if the echoclip device facilitates imaging of coronary bypass anastomoses during coronary artery bypass surgery in humans to the same degree as was shown in animal studies. Ultrasonography will be used for visualizing all coronary anastomoses during 100 elective low-risk (logistic II EuroSCORE <6) on-pump coronary artery bypass procedures. It will be registered if the heel, the central portion and the toe of the anastomosis can be visualized in end-to-side and side-to-side anastomoses.Use of the echoclip devise will be considered a success if at least 80% of all parts of the anastomoses can be visualized either directly or by electronic reading using a special developed algorithm that may identify the inner border of the anastomoses.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||During Coronary Artery Bypass Surgery. A Feasibility Study.|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Echoclip device
Ultrasonography using the echoclip device
An ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg,Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging will be used for visualising the coronary bypass anastomoses during surgery
- Quality of periferal coronary artery bypass anastomotic structures [ Time Frame: Peroperative ]Ultrasonographic images of periferal coronary artery bypass anastomoses will be studied in order to evaluate if the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) can be visualized directly on the screen using the echoclip device.
- Automatic quality control of periferal coronary artery bypass anastomotic structures [ Time Frame: Peroperative ]To quantify the anastomotic quality from epicardial utrasound images obtained peroperative, the area of anastomotic structures from various locations of the anastomoses (heel, central portion and the to toe) will be meassured using an automatic anastomosis segmentation algorithm to extract the area of the anastomotic structures. The ultrasound images obtained peroperative will be analyzed in the Laboratory when 50 patients and 100 patients have been included in the study, respectively.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919124
|Aalborg University Hospital|
|Aalborg, Denmark, 9100|
|Principal Investigator:||Jan J Andreasen, MD, PhD||Aalborg University Hospital and Aalborg University|