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CompletedNCT06464354Updated Jun 18, 2024

Comparison of the Mammary Harvesting Technique

An observational study in Ischemic Heart Disease, sponsored by University Hospital Ostrava. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by University Hospital Ostrava · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

The skeletonization technique of left internal artery (LIMA) harvesting is reported as more spar-ing to the vascular supply of the sternum. Some studies report a greater length and greater flow of the graft additionally. The aim of our study was to measure the difference in post-op sternal blood supply compared to the pedicle harvesting technique and to measure the length and flow of the LIMA graft.

Read the detailed description

A total of 90 patients were examined in a prospective randomized study. In 60 patients referred for coronary artery bypass grafting (CABG), LIMA was harvested, one-half (n=30) skeletonized, and one-half (n=30) with a pedicle. Thirty patients operated via sternotomy without LIMA harvesting (other procedures, for instance, valve surgery) were the control group. In patients undergoing LIMA harvest, harvest duration, graft length, and graft free flow were measured at defined arterial pressure. In all patients, the sternal blood flow was examined by active dynamic thermography (DIRT): first preoperatively and on 4th postoperative day. During this, the time of spontaneous rewarming of the skin surface after the application of a cold stimulus was measured in the caudal part of the sternum. The difference between postoperative and preoperative time was calculated and compared between groups.

02

Conditions studied

  • Ischemic Heart Disease

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Keywords

  • sternotomy
  • thermography
  • coronary bypass
  • LIMA
  • skeletonization technique
03

In context

Myocardial Ischemia

3,242 studies on the registry are indexed under Myocardial Ischemia; 390 are open to participants now.

This study's enrollment of 90 is below the median of 333 across 1,142 observational studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

University Hospital Ostrava is the lead sponsor of 148 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients undergoing elective cardiac surgery via sternotomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective cardiac surgery procedure via median sternotomy
  • The left mammary artery (LIMA) harvesting for coronary bypass planned as a part of the operation - Group 1 and 2
  • Other cardiac surgery procedures without the LIMA harvesting (valve surgery for instance) - Control group
  • Signing of the informed consent

Exclusion criteria

Exclusion Criteria:

  • Emergent surgery
  • Re-operation
  • Re-sternotomy
  • Thoracotomy approach
  • Harvesting of both mammary arteries (BIMA)
  • Endocarditis
  • Ongoing non-cardiac infection
  • Fever
  • Circulatory failure
  • Ongoing administration of catecholamines to patient
  • Unsigned informed consent
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • LIMA - pedicle

    Procedure: The mammary artery harvesting by the pedicle technique

  • LIMA - skeletonised

    Procedure: The mammary harvesting using the skeletonization technique

  • Control group - LIMA not harvested

    Procedure: No intervention

Interventions

  • ProcedureThe mammary artery harvesting by the pedicle technique

    The mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group.

  • ProcedureThe mammary harvesting using the skeletonization technique

    The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.

  • ProcedureNo intervention

    No intervention was used in the control study group.

06

What researchers measure

Primary outcomes

  1. Rewarming time difference

    Duration of spontaneous rewarming of the skin surface of the caudal sternum after a cold stimulus, measured from 24°C to 27°C. Unit: seconds (s)

    Time frame: first preoperatively and on 4th postoperative day

Secondary outcomes

  1. Duration of the mammary graft harvesting

    Time from the start of the harvesting to complete graft release. Unit: minute (min).

    Time frame: during surgery, immediately after the graft harvesting

  2. Length of the mammary artery graft

    Length from the distance of the graft from the chest wall to its distal end. Unit: millimeter (mm).

    Time frame: during surgery, immediately after the graft harvesting

  3. Free outflow of the mammary artery

    After trimming the distal clip on the graft at an arterial pressure of 70 mmHg, free flow for 30 seconds, then multiplied by two. Unit: millilitre per minute (ml/min).

    Time frame: during surgery, just before the graft use

07

Study locations

1 site
  • University Hospital Ostrava
    Ostrava, Moravial-Silesian Region 70852, Czechia
08

References and documents

Publications

  • Cheng K, Rehman SM, Taggart DP. A Review of Differing Techniques of Mammary Artery Harvesting on Sternal Perfusion: Time for a Randomized Study? Ann Thorac Surg. 2015 Nov;100(5):1942-53. doi: 10.1016/j.athoracsur.2015.06.087. Epub 2015 Sep 26. PubMed 26410160 ↗
  • Alom S, Yang N, Bin Saeid J, Zeinah M, Harky A. Harvesting internal mammary artery: a narrative review. J Cardiovasc Surg (Torino). 2020 Dec;61(6):790-801. doi: 10.23736/S0021-9509.20.11216-3. Epub 2020 Sep 4. PubMed 32885924 ↗
  • Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. PubMed 34132753 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Dec 2023, 6 months.

Of 401 non-industry observational studies under Myocardial Ischemia, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 112. This study's 6 months is below that.

Counting every sponsor, half of 462 studies reached it within 45 months; a quarter within 23 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2024
First posted
Jun 18, 2024
StartActual
Jun 1, 2023
Primary completionActual
Dec 31, 2023
CompletionActual
Dec 31, 2023
Last update
Jun 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06464354
Responsible party
Sponsor
First posted
Jun 18, 2024
Start date
Jun 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Jun 18, 2024

Study contacts

Radim Brát, Assoc.Prof.,MD,PhD,MBA
study chair · University Hospital Ostrava
Jiří Sieja, MD
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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