Epicardial Echocardiography of Coronary Anastomoses Using the Echoclip Device

NCT02919124 | Completed DMC

• 1 other identifier: 0089Y
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Arteriosclerosis

Keywords

Coronary artery bypass grafting; Anastomosis; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  Peroperative

Secondary Outcomes (1)

• Automatic quality control of periferal coronary artery bypass anastomotic structures

  Peroperative

Study Arms (1)

Echoclip device

EXPERIMENTAL

Ultrasonography using the echoclip device

Device: Echoclip

Interventions

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

Echoclip device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator
• Medistim ASA: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Related Publications (4)

• 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.

  PMID: 21168035 RESULT

• Jorgensen AS, Andersen MS, Ostergaard LR, Schmidt SE, Nohr D, Andreasen JJ. A laboratory feasibility study using a computer algorithm for anastomosis segmentation of epicardial ultrasonography images from distal coronary artery bypass anastomoses. J Cardiothorac Surg. 2025 Jan 6;20(1):34. doi: 10.1186/s13019-024-03187-8.

  PMID: 39762954 DERIVED

• 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.

  PMID: 31915030 DERIVED

• 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.

  PMID: 30866994 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jan J Andreasen, MD, PhD

  Aalborg University Hospital and Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, consultant

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 29, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 3, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)