Comparison of the Mammary Harvesting Technique

June 12, 2024 updated by: University Hospital Ostrava

Comparison of the Effect of Mammary Artery Harvesting Technique to Sternal Blood Supply Using Non-contact Dynamic Thermography

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravial-Silesian Region
      • Ostrava, Moravial-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective cardiac surgery via sternotomy

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
LIMA - pedicle
Procedure: The mammary artery harvesting by the pedicle technique
The mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group.
LIMA - skeletonised
Procedure: The mammary harvesting using the skeletonization technique
The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.
Control group - LIMA not harvested
Procedure: No intervention
No intervention was used in the control study group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rewarming time difference
Time Frame: first preoperatively and on 4th postoperative day
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)
first preoperatively and on 4th postoperative day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of the mammary graft harvesting
Time Frame: during surgery, immediately after the graft harvesting
Time from the start of the harvesting to complete graft release. Unit: minute (min).
during surgery, immediately after the graft harvesting
Length of the mammary artery graft
Time Frame: during surgery, immediately after the graft harvesting
Length from the distance of the graft from the chest wall to its distal end. Unit: millimeter (mm).
during surgery, immediately after the graft harvesting
Free outflow of the mammary artery
Time Frame: during surgery, just before the graft use
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).
during surgery, just before the graft use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Ostrava

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Radim Brát, Assoc.Prof.,MD,PhD,MBA, University Hospital Ostrava
  • Principal Investigator: Jiří Sieja, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KCHC-01-mammary artery
  • SGS25/LF/2023 (Other Grant/Funding Number: University of Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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