Clinical trial NCT05562908: Skeletonised Versus Pedicled Internal Thoracic Artery
Official title: Skeletonised Versus Pedicled Internal Thoracic Artery - A Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: coronary artery diseases
left internal mammary artery
LIMA harvesting
flow
quality of life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Odense Patient Data Explorative Network
name: GCP-unit at Odense University Hospital
First posted: 2022-10-03
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised trial
Primary purpose: TREATMENT

Brief summary: It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested LIMA.

The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.

The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.

The study design is an experimental randomized controlled trial in a single centre.

Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.

Study Unit: Test-days within subject and subject

The study will address two main hypotheses in CABG patients:

1. That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
2. Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
* On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
* Patients aged \>18
* Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)

Exclusion Criteria:

* CABG combined with other heart surgery, except from LAAX
* Previous heart surgery
* LVEF \< 40% (there is a known higher risk of postoperative complications with low LVEF)
* Known cancers (there is a known higher risk of postoperative complication)
* Thoracic radiation therapy (there is a known higher risk of postoperative complication)
* Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)
* Patients not able to understand written consent
* Urgent and emergent surgery (there is a known higher risk of postoperative complication)

Primary outcomes:
measure: Differences in flow in LIMA and pulssatility index between the three groups.
timeFrame: Perioperative - After weaning off the extracorporeal circulation just before closing the thorax
Secondary outcomes:
measure: Postoperative bleeding
timeFrame: Postoperative bleeding is measured from the end of the operation to removal of the mediastinal drains in the intensive care unit
measure: Re-operation due to bleeding
timeFrame: Up to 48 hours calculated from the end of primaery surgery
measure: Re-operation due to ischemia
timeFrame: Up to 48 hours calculated from the end of primaery surgery
measure: Pleurocentesis
timeFrame: Up to 10 days calculated from the end of primaery surgery
measure: Myocardial injury - creatine kinase-MB (CK-MB)
timeFrame: Routine bloodsample measured four hours after aortic cross clamp removal.
measure: Myocardial injury - cardiac troponin (cTn)
timeFrame: Routine bloodsample measured four hours after aortic cross clamp removal.
measure: Differences in pre and post operative regional oxygen saturation on the thorax.
timeFrame: Measured 7 days prior to surgery and again 3 days after surgery
measure: Length of stay on ICU
timeFrame: Day of surgery to the day of discharge from ICU. Up to 52 weeks
measure: Length of stay in hospital
timeFrame: Day of surgery to the day of discharge from hospital. Up to 52 weeks
measure: EQ-5D-5L questionnaire: differences in self reported assessment of patient quality of life between the 3 groups
timeFrame: Questionnaires uptained the week before the date of surgery and again 3, 30, and 180 days after surgery.
measure: Telephone interview - Questions regarding pain, numbness and wound healing around the thoracic incision.
timeFrame: 180 ± 7 days calculated from the date of surgery.
measure: Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - early
timeFrame: Early (≤30 days)
measure: Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Intermediate
timeFrame: Intermediate (≤180 days)
measure: Rate of readmission to hospital due to Major adverse cardiac and cerebrovascular events (MACCE) - Long
timeFrame: Long (≤2 years)
measure: Rate of mortality due to cardiac event - Early
timeFrame: Early (≤30 days)
measure: Rate of mortality due to cardiac event - Intermediate
timeFrame: Intermediate (≤180 days)
measure: Rate of mortality due to cardiac event - Iong
timeFrame: Long (≤2 years)
measure: Rate of all-cause mortality - Early
timeFrame: Early (≤30 days)
measure: Rate of all-cause mortality - Intermediate
timeFrame: Intermediate (≤180 days)
measure: Rate of all-cause mortality - long
timeFrame: Long (≤ 2 years)
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Cardio, Vascular and Thoracic Surgery
state: Region Of Southern Denmark
Study officials:
affiliation: Odense University Hospital
name: Lars P Riber, MD, Ph.D. DMSc
role: STUDY_DIRECTOR
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