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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
Sponsor:
Collaborators:
Aalborg University
Medistim ASA
Information provided by (Responsible Party):
Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Device: Echoclip Not Applicable

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:

  1. The transducer must be kept in a steady position relative to the anastomosis for 5 to 10 cardiac cycles to minimize frame-rate variability.
  2. Ultrasound gel must be kept in contact with the transducer and the region studied.
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Echoclip device
Ultrasonography using the echoclip device
Device: Echoclip
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919124


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Aalborg University Hospital
Aalborg University
Medistim ASA
Investigators
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Principal Investigator: Jan J Andreasen, MD, PhD Aalborg University Hospital and Aalborg University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jan Jesper Andreasen, Professor, MD, PhD, Professor, consultant, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02919124    
Other Study ID Numbers: 0089Y
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data are available for Monitor
Keywords provided by Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital:
Coronary artery bypass grafting
Anastomosis
Ultrasonography
Additional relevant MeSH terms:
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Arteriosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases