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Trial record 1 of 1 for:    Echoclip
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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

Tracking Information
First Submitted Date  ICMJE September 25, 2016
First Posted Date  ICMJE September 29, 2016
Last Update Posted Date January 3, 2020
Study Start Date  ICMJE September 2016
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2016)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device
Official Title  ICMJE During Coronary Artery Bypass Surgery. A Feasibility Study.
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Arteriosclerosis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Echoclip device
Ultrasonography using the echoclip device
Intervention: Device: Echoclip
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2020)
56
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
100
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02919124
Other Study ID Numbers  ICMJE 0089Y
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data are available for Monitor
Responsible Party Jan Jesper Andreasen, Professor, MD, PhD, Aalborg University Hospital
Study Sponsor  ICMJE Aalborg University Hospital
Collaborators  ICMJE
  • Aalborg University
  • Medistim ASA
Investigators  ICMJE
Principal Investigator: Jan J Andreasen, MD, PhD Aalborg University Hospital and Aalborg University
PRS Account Aalborg University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP