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Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device

Primary Purpose

Coronary Arteriosclerosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Echoclip
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Arteriosclerosis focused on measuring Coronary artery bypass grafting, Anastomosis, Ultrasonography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective on-pump coronary artery bypass surgery
  • Surgery planned to be performed by specialist in cardiac surgery.
  • Logistic euroSCORE II <6%.
  • Must be able to read and understand the Danish
  • Written informed acceptance to participate

Exclusion Criteria:

  • Planned off-pump surgery.
  • Peroperativ conversion to off-pump surgery.
  • Logistic EuroSCORE II ≥ 6.
  • The patient do not understand written or spoken Danish.
  • Surgery within 24 hours after admittance to hospital
  • Patients in whom the surgeon wants to end the surgery in a hurry due to e.g. hemodynamic problems or peroperative complications.
  • The surgeon is not a specialist in cardiac surgery, e.g. surgeon in training.
  • Pregnant or brest feeding patient.
  • No written acceptance to participate.

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Echoclip device

Arm Description

Ultrasonography using the echoclip device

Outcomes

Primary Outcome Measures

Quality of periferal coronary artery bypass anastomotic structures
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.

Secondary Outcome Measures

Automatic quality control of periferal coronary artery bypass anastomotic structures
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.

Full Information

First Posted
September 25, 2016
Last Updated
January 2, 2020
Sponsor
Aalborg University Hospital
Collaborators
Aalborg University, Medistim ASA
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1. Study Identification

Unique Protocol Identification Number
NCT02919124
Brief Title
Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device
Official Title
During Coronary Artery Bypass Surgery. A Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Aalborg University, Medistim ASA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate whether use of the echoclip device (an ultrasound transducer positioning device which can stabilize the involved part of the myocardium on the beating heart) facilitates imaging of coronary bypass anastomoses during coronary bypass surgery. A total of 100 low risk patients undergoing elective on-pump coronary bypass surgery will be included in the study in order to evaluate if the surgeons can visualize the coronary anastomoses before closure of the sternum. Ultrasonograpic pictures will be analyzed directly peroperatively and electronically post-operatively in order to evaluate if selected areas of the anastomoses can be visualized. Use of the echoclip devise will be considered a success if at least 80% of the anastomoses can be visualized.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
Coronary artery bypass grafting, Anastomosis, Ultrasonography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echoclip device
Arm Type
Experimental
Arm Description
Ultrasonography using the echoclip device
Intervention Type
Device
Intervention Name(s)
Echoclip
Intervention Description
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
Primary Outcome Measure Information:
Title
Quality of periferal coronary artery bypass anastomotic structures
Description
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.
Time Frame
Peroperative
Secondary Outcome Measure Information:
Title
Automatic quality control of periferal coronary artery bypass anastomotic structures
Description
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.
Time Frame
Peroperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective on-pump coronary artery bypass surgery Surgery planned to be performed by specialist in cardiac surgery. Logistic euroSCORE II <6%. Must be able to read and understand the Danish Written informed acceptance to participate Exclusion Criteria: Planned off-pump surgery. Peroperativ conversion to off-pump surgery. Logistic EuroSCORE II ≥ 6. The patient do not understand written or spoken Danish. Surgery within 24 hours after admittance to hospital Patients in whom the surgeon wants to end the surgery in a hurry due to e.g. hemodynamic problems or peroperative complications. The surgeon is not a specialist in cardiac surgery, e.g. surgeon in training. Pregnant or brest feeding patient. No written acceptance to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan J Andreasen, MD, PhD
Organizational Affiliation
Aalborg University Hospital and Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data are available for Monitor
Citations:
PubMed Identifier
21168035
Citation
Staalsen NH, Kjaergaard B, Andreasen JJ. A new technique facilitating intraoperative, high-frequency echocardiography of coronary bypass graft anastomoses. J Thorac Cardiovasc Surg. 2011 Jan;141(1):295-6. doi: 10.1016/j.jtcvs.2009.11.074. No abstract available.
Results Reference
result
PubMed Identifier
31915030
Citation
Andreasen JJ, Nohr D, Jorgensen AS, Haahr PE. Peroperative epicardial ultrasonography of distal coronary artery bypass graft anastomoses using a stabilizing device. A feasibility study. J Cardiothorac Surg. 2020 Jan 8;15(1):3. doi: 10.1186/s13019-020-1057-x.
Results Reference
derived
PubMed Identifier
30866994
Citation
Andreasen JJ, Nohr D, Jorgensen AS. A case report on epicardial ultrasonography of coronary anastomoses using a stabilizing device without the use of ultrasound gel. J Cardiothorac Surg. 2019 Mar 13;14(1):59. doi: 10.1186/s13019-019-0882-2.
Results Reference
derived

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Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device

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