Coronary Artery DiseaseNCT03657199
Early Silent Graft Failure in Off-pump Coronary Artery Bypass Grafting: A Computed Tomography Analysis
An observational study of Coronary Artery Disease and Bypass Complication, run by Triemli Hospital.
Trial summary
Aortocoronary bypass surgery is one of the most common operations in the western world. The goal of the surgeon is to perform a complete revascularization of the coronary arteries with the best, available bypass material. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Bypass Complication, Graft Failure
- What is being tested?
- Cardiac computed tomography
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jul 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients after off-pump coronary artery bypass grafting from January 2017 till April 2018, who received a postoperative computed tomography for the evaluation of the bypass patency before discharge
Who may be able to join
- patients after off-pump coronary artery bypass grafting
- postoperative computed tomography for the evaluation of the bypass patency before discharge
Who cannot join
- Operation with a heart-lung machine
- Combined interventions
- Postoperative emergency coronary angiography
- There is a documented rejection
About this study
Aortocoronary bypass surgery is one of the most common operations in the western world. The goal of the surgeon is to perform a complete revascularization of the coronary arteries with the best, available bypass material.
Aortocoronary bypass surgery can be performed with (on-pump) or without (off-pump) the heart lung machine. If the operation is performed without the heart lung machine, the heart is continuously beating while the surgeon sews the bypass to the diseased coronary artery. In randomized trials, the benefits of the off-pump technique in the hands of experienced surgeons in terms of shorter operating times, less transfusions and less pulmonary and renal complications were proven. A criticism of the off-pump technique is the reduced number of distal anastomoses, which means that fewer coronary arteries may be connected with bypass grafts because of the technically sophisticated situation. A worse quality of the connection (anastomosis) between coronary artery and bypass is often discussed, leading to a bypass occlusion already in the early stage after surgery resulting in more re-interventions on the coronary vessels. So-called silent bypass failure without clinical correlation has been examined in three relevant studies including both, the on- and the off-pump technique, with inhomogenous results. In addition to the technique, other parameters such as the degree of narrowing (stenosis) of the diseased coronary artery and collateralization of a closed coronary artery may play a role in early occlusion.
Read more
All bypass patients after off-pump surgery receive routinely a computed tomographic examination of the heart. With this method, silent bypass occlusions without clinical correlation, i.e. cardiac infarction, elevated cardiac laboratory parameters or ECG changes, can be detected easily. In case of an occlusion of a relevant bypass, an intervention before discharge can be planned and performed.
We would like to investigate the occlusion rate of this retrospective patient cohort after off-pump surgery and the potential risk factors, that may influence on early graft failure. We hypothesize, that early graft failure depends not only on the choice of the graft material, but also on the local grade of coronary stenosis, the collateralisation of occluded coronary vessels and the intraoperative flow results, as well as on the region of the target vessel.
- Conditions
- Coronary Artery Disease, Bypass Complication, Graft Failure
- Being tested
- Cardiac computed tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac computed tomographyDiagnostic test
Routine computed tomography of the heart before discharge
| Study group | Role | What they receive |
|---|---|---|
| Bypass graft failure | Patients with at least one detected graft failure after routine cardiac computed tomography before discharge Receives: Diagnostic Test: Cardiac computed tomography | |
| No bypass graft failure | Patients without occluded bypass grafts after routine cardiac computed tomography before discharge Receives: Diagnostic Test: Cardiac computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative graft failure
Assessment of graft failure by computed tomography in all patients after isolated off-pump surgery
Measured: first week after aortocoronary bypass grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start1 Jan 2017
- Primary completion20 Apr 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triemli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicja Zientara, Triemli Hospital
- Investigators
- Alicja Zientara, Dr, Principal investigator, Triemli Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657199
- Sponsor's protocol ID
- KEK-ID 2017-02315
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zientara A, Rings L, Bruijnen H, Dzemali O, Odavic D, Haussler A, Gruszczynski M, Genoni M. Early silent graft failure in off-pump coronary artery bypass grafting: a computed tomography analysisdagger. Eur J Cardiothorac Surg. 2019 Nov 1;56(5):919-925. doi: 10.1093/ejcts/ezz112.
PubMed 31006005
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Silent Graft Failure in Off-pump Coronary Artery Bypass Grafting: A Computed Tomography Analysis
- ClinicalTrials.gov ID
- NCT03657199
- Acronym / sponsor ID
- KEK-ID 2017-02315
- Conditions
- Coronary Artery Disease, Bypass Complication, Graft Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Triemli HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 4 Sep 2018 (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.
Aortocoronary bypass surgery is one of the most common operations in the western world. The goal of the surgeon is to perform a complete revascularization of the coronary arteries with the best, available bypass material.
Aortocoronary bypass surgery can be performed with (on-pump) or without (off-pump) the heart lung machine. If the operation is performed without the heart lung machine, the heart is continuously beating while the surgeon sews the bypass to the diseased coronary artery. In randomized trials, the benefits of the off-pump technique in the hands of experienced surgeons in terms of shorter operating times, less transfusions and less pulmonary and renal complications were proven. A criticism of the off-pump technique is the reduced number of distal anastomoses, which means that fewer coronary arteries may be connected with bypass grafts because of the technically sophisticated situation. A worse quality of the connection (anastomosis) between coronary artery and bypass is often discussed, leading to a bypass occlusion already in the early stage after surgery resulting in more re-interventions on the coronary vessels. So-called silent bypass failure without clinical correlation has been examined in three relevant studies including both, the on- and the off-pump technique, with inhomogenous results. In addition to the technique, other parameters such as the degree of narrowing (stenosis) of the diseased coronary artery and collateralization of a closed coronary artery may play a role in early occlusion.
All bypass patients after off-pump surgery receive routinely a computed tomographic examination of the heart. With this method, silent bypass occlusions without clinical correlation, i.e. cardiac infarction, elevated cardiac laboratory parameters or ECG changes, can be detected easily. In case of an occlusion of a relevant bypass, an intervention before discharge can be planned and performed.
We would like to investigate the occlusion rate of this retrospective patient cohort after off-pump surgery and the potential risk factors, that may influence on early graft failure. We hypothesize, that early graft failure depends not only on the choice of the graft material, but also on the local grade of coronary stenosis, the collateralisation of occluded coronary vessels and the intraoperative flow results, as well as on the region of the target vessel.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bypass graft failure | – | Diagnostic Test: Cardiac computed tomographyPatients with at least one detected graft failure after routine cardiac computed tomography before discharge |
| No bypass graft failure | – | Diagnostic Test: Cardiac computed tomographyPatients without occluded bypass grafts after routine cardiac computed tomography before discharge |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients after off-pump coronary artery bypass grafting from January 2017 till April 2018, who received a postoperative computed tomography for the evaluation of the bypass patency before discharge
Key inclusion criteria (2 listed)
- patients after off-pump coronary artery bypass grafting
- postoperative computed tomography for the evaluation of the bypass patency before discharge
Key exclusion criteria (4 listed)
- Operation with a heart-lung machine
- Combined interventions
- Postoperative emergency coronary angiography
- There is a documented rejection
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 |
|---|---|---|
| Cardiac computed tomographyRoutine computed tomography of the heart before discharge | Diagnostic test | Bypass graft failure, No bypass graft failure |
Primary outcome
Early postoperative graft failure
Time frame: first week after aortocoronary bypass grafting
Assessment of graft failure by computed tomography in all patients after isolated off-pump surgery
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 5 Sep 2018.
- Derived from this study: PubMed 31006005Zientara A, Rings L, Bruijnen H, Dzemali O, Odavic D, Haussler A, Gruszczynski M, Genoni M. Early silent graft failure in off-pump coronary artery bypass grafting: a computed tomography analysisdagger. Eur J Cardiothorac Surg. 2019 Nov 1;56(5):919-925. doi: 10.1093/ejcts/ezz112.
- Individual participant dataSharing planned: Undecided
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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.
Alicja Zientara, Dr principal investigator
Triemli Hospital Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Bypass Complication, run by Triemli Hospital.
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 2 inclusion and 4 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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Early postoperative graft failure (time frame: first week after aortocoronary bypass grafting). 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 NCT03657199, which also lists 1 linked publication.
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 5 Sep 2018.