Ischemic Heart DiseaseNCT06464354
Comparison of the Mammary Harvesting Technique
An observational study of Ischemic Heart Disease, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- The mammary artery harvesting by the pedicle technique and The mammary harvesting using the skeletonization technique
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing elective cardiac surgery via sternotomy
Who may be able to join
- 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
Who cannot join
- Emergent surgery
- Re-operation
- Re-sternotomy
- Thoracotomy approach
- Harvesting of both mammary arteries (BIMA)
- Endocarditis
Show all 11Show fewer
- Ongoing non-cardiac infection
- Fever
- Circulatory failure
- Ongoing administration of catecholamines to patient
- Unsigned informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravial-Silesian Region, 70852
About this study
Official title: 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.
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.
- Conditions
- Ischemic Heart Disease
- Being tested
- The mammary artery harvesting by the pedicle technique, The mammary harvesting using the skeletonization technique, No intervention
- Keywords
- sternotomy, thermography, coronary bypass, LIMA, skeletonization technique
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The mammary artery harvesting by the pedicle techniqueProcedure or surgery
The mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group.
The mammary harvesting using the skeletonization techniqueProcedure or surgery
The mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group.
No interventionProcedure or surgery
No intervention was used in the control study group.
| Study group | Role | What they receive |
|---|---|---|
| LIMA - pedicle | Not described Receives: Procedure: The mammary artery harvesting by the pedicle technique | |
| LIMA - skeletonised | Not described Receives: Procedure: The mammary harvesting using the skeletonization technique | |
| Control group - LIMA not harvested | Not described Receives: Procedure: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: first preoperatively and on 4th postoperative day
Secondary outcomes (3)
Duration of the mammary graft harvesting
Time from the start of the harvesting to complete graft release. Unit: minute (min).
Measured: during surgery, immediately after the graft harvesting
Length of the mammary artery graft
Length from the distance of the graft from the chest wall to its distal end. Unit: millimeter (mm).
Measured: during surgery, immediately after the graft harvesting
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).
Measured: during surgery, just before the graft use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radim Brát, Assoc.Prof.,MD,PhD,MBA, Study chair, University Hospital OstravaJiří Sieja, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464354
- Sponsor's protocol ID
- KCHC-01-mammary artery
- Other IDs
- SGS25/LF/2023
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
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 26410160Alom 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 32885924Lamy 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Mammary Artery Harvesting Technique to Sternal Blood Supply Using Non-contact Dynamic Thermography
- ClinicalTrials.gov ID
- NCT06464354
- Acronym / sponsor ID
- KCHC-01-mammary artery
- Conditions
- Ischemic Heart Disease
- Keywords
- sternotomy, thermography, coronary bypass, LIMA, skeletonization technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery via sternotomy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Emergent surgery
- Re-operation
- Re-sternotomy
- Thoracotomy approach
- Harvesting of both mammary arteries (BIMA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The mammary artery harvesting by the pedicle techniqueThe mammary artery harvesting by the pedicle technique was used in the LIMA pedicle study group. | Procedure or surgery | LIMA - pedicle |
| The mammary harvesting using the skeletonization techniqueThe mammary harvesting using the skeletonization technique was used in the LIMA skeletonized study group. | Procedure or surgery | LIMA - skeletonised |
| No interventionNo intervention was used in the control study group. | Procedure or surgery | Control group - LIMA not harvested |
Primary outcome
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)
3 secondary outcomes
Duration of the mammary graft harvesting
Time frame: during surgery, immediately after the graft harvesting
Length of the mammary artery graft
Time frame: during surgery, immediately after the graft harvesting
Free outflow of the mammary artery
Time frame: during surgery, just before the graft use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 26410160Cheng 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.
- Background: PubMed 32885924Alom 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.
- Background: PubMed 34132753Lamy 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radim Brát, Assoc.Prof.,MD,PhD,MBA study chair
University Hospital Ostrava
Jiří Sieja, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rewarming time difference (time frame: first preoperatively and on 4th postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464354, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.