Coronary Bypass Graft OcclusionNCT04595630
Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
An observational study of Coronary Bypass Graft Occlusion, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.
Trial summary
This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Bypass Graft Occlusion
- What is being tested?
- data collection from the hospital records
- How many people
- 480 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jul 2021to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.
Who may be able to join
- patients with isolated coronary bypass surgery
Who cannot join
- Patients withholding or lacking informed consent
- Patients requiring a concomitant procedure
- Patients with known allergy to iodine-containing contrast agents
- Renal function impairment (serum creatinine >140 mmol/l; estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
- Pregnancy
- Unstable clinical state or severe heart failure
- Patients with registered MI and registered bypass occlusion in coronary angiogram
- Patients that didn't undergo a CCT prior to discharge
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Croatia1 site, 1 recruiting
- Not yet recruiting
University Hospital Centre Zagreb
Zagreb, 10 000
Hrovje Gasparovic, Prof., 0038512367532, predstojnik.kkk@kbc-zagreb.hr
Poland1 site, 1 recruiting
- Not yet recruiting
Wroclaw Medical University
Wroclaw, Borowska, 213
Marek Jasinski, Prof., +48717364100, marek.jasinski@umw.edu.pl
Switzerland1 site, 1 recruiting
- Recruiting
Department for Cardiac Surgery, University Hospital Basel
Basel, 4031
Denis Berdajs, Prof., +41 61 328 71 80, denis.berdajs@usb.ch
About this study
This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.
Read the detailed description
The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.
- Conditions
- Coronary Bypass Graft Occlusion
- Being tested
- data collection from the hospital records
- Keywords
- coronary artery bypass grafting (CABG), cardiac biomarkers, coronary revascularization, high-sensitivity cardiac troponin (hs-cTn), myocardial infarction (MI), Coronary Computed Tomography (CCT), early coronary bypass graft occlusion
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection from the hospital recordsOther
The clinical data from the patients enrolled in the study, such as the medical history, functional state, and EuroSCORE, and the hematological, basic renal, hepatic, and metabolic chemistry findings (including cTn as defined per the protocol), the operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts, the number of distal anastomoses, flow measured at all bypass grafts at the end of the intervention and the need for an assist device) and CCT scan data (at discharge from hospital facility) will be obtained from the hospital records. The data will be entered into a database.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hs-cTn level (ng/L)
hs-cTn level following CABG to correlate between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT
Measured: Day 0 to discharge date (max 10 days)
Secondary outcomes (6)
All-cause mortality during hospital stay (death before discharge)
All-cause mortality during hospital stay (death before discharge)
Measured: Day 0 to discharge date (max 10 days)
Cardiac-related mortality during hospital stay
Cardiac-related mortality during hospital stay
Measured: Day 0 to discharge date (max 10 days)
Myocardial infarction during hospital stay
Myocardial infarction during hospital stay
Measured: Day 0 to discharge date (max 10 days)
Surgical or percutaneous coronary re-intervention during hospital stay
Surgical or percutaneous coronary re-intervention during hospital stay
Measured: Day 0 to discharge date (max 10 days)
Stroke rate during hospital stay
Stroke rate during hospital stay
Measured: Day 0 to discharge date (max 10 days)
Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay
Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay. MACCE is defined as a combined event of in-hospital mortality, stroke and myocardial infarction.
Measured: Day 0 to discharge date (max 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Jul 2021
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
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 Bypass Graft OcclusionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Berdajs, Prof. Dr. med., Principal investigator, Department of Cardiac Surgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595630
- Sponsor's protocol ID
- 2020-02257; ch20Berdajs
- Status last verified
- Feb 2025
- First submitted
- 6 Oct 2020
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salikhanov I, Koechlin L, Gahl B, Voehringer L, Reuthebuch O, Dimanski D, Mawad BM, Berdajs D. Survival, adverse events and management of silent in-hospital coronary bypass graft occlusion. Open Heart. 2025 Jul 7;12(2):e003368. doi: 10.1136/openhrt-2025-003368.
PubMed 40623893
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
- ClinicalTrials.gov ID
- NCT04595630
- Acronym / sponsor ID
- 2020-02257; ch20Berdajs
- Conditions
- Coronary Bypass Graft Occlusion
- Keywords
- coronary artery bypass grafting (CABG), cardiac biomarkers, coronary revascularization, high-sensitivity cardiac troponin (hs-cTn), myocardial infarction (MI), Coronary Computed Tomography (CCT), early coronary bypass graft occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 Oct 2020 (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.
This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.
Detailed description
The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.
Key inclusion criteria (1 listed)
- patients with isolated coronary bypass surgery
Key exclusion criteria (8 listed)
- Patients withholding or lacking informed consent
- Patients requiring a concomitant procedure
- Patients with known allergy to iodine-containing contrast agents
- Renal function impairment (serum creatinine >140 mmol/l; estimated glomerular filtration rate (GFR) <30 ml/min/1.73 m2).
- Pregnancy
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 |
|---|---|---|
| data collection from the hospital recordsThe clinical data from the patients enrolled in the study, such as the medical history, functional state, and EuroSCORE, and the hematological, basic renal, hepatic, and metabolic chemistry findings (including cTn as defined per the protocol), the operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts, the number of distal anastomoses, flow measured at all bypass grafts at the end of the intervention and the need for an assist device) and CCT scan data (at discharge from hospital facility) will be obtained from the hospital records. The data will be entered into a database. | Other | – |
Primary outcome
Change in hs-cTn level (ng/L)
Time frame: Day 0 to discharge date (max 10 days)
hs-cTn level following CABG to correlate between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT
6 secondary outcomes
All-cause mortality during hospital stay (death before discharge)
Time frame: Day 0 to discharge date (max 10 days)
Cardiac-related mortality during hospital stay
Time frame: Day 0 to discharge date (max 10 days)
Myocardial infarction during hospital stay
Time frame: Day 0 to discharge date (max 10 days)
Surgical or percutaneous coronary re-intervention during hospital stay
Time frame: Day 0 to discharge date (max 10 days)
Stroke rate during hospital stay
Time frame: Day 0 to discharge date (max 10 days)
Incidence of major adverse cardiac and cerebrovascular events (MACCE) during hospital stay
Time frame: Day 0 to discharge date (max 10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Derived from this study: PubMed 40623893Salikhanov I, Koechlin L, Gahl B, Voehringer L, Reuthebuch O, Dimanski D, Mawad BM, Berdajs D. Survival, adverse events and management of silent in-hospital coronary bypass graft occlusion. Open Heart. 2025 Jul 7;12(2):e003368. doi: 10.1136/openhrt-2025-003368.
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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.
Denis Berdajs, Prof. Dr. med. principal investigator
Department of Cardiac Surgery, University Hospital Basel
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Bypass Graft Occlusion, run by University Hospital, Basel, Switzerland at 3 sites in 3 countries.
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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Croatia, Poland, Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Denis Berdajs, Prof. Dr. med. (+41 61 328 71 80, denis.berdajs@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hs-cTn level (ng/L) (time frame: Day 0 to discharge date (max 10 days)). 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 NCT04595630, 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 25 Feb 2025.