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Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

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ClinicalTrials.gov Identifier: NCT04595630
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Coronary Bypass Graft Occlusion Other: data collection from the hospital records

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
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Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: data collection from the hospital records
    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.

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. All-cause mortality during hospital stay (death before discharge) [ Time Frame: Day 0 to discharge date (max 10 days) ]
    All-cause mortality during hospital stay (death before discharge)

  2. Cardiac-related mortality during hospital stay [ Time Frame: Day 0 to discharge date (max 10 days) ]
    Cardiac-related mortality during hospital stay

  3. Myocardial infarction during hospital stay [ Time Frame: Day 0 to discharge date (max 10 days) ]
    Myocardial infarction during hospital stay

  4. Surgical or percutaneous coronary re-intervention during hospital stay [ Time Frame: Day 0 to discharge date (max 10 days) ]
    Surgical or percutaneous coronary re-intervention during hospital stay

  5. Stroke rate during hospital stay [ Time Frame: Day 0 to discharge date (max 10 days) ]
    Stroke rate during hospital stay

  6. Incidence of major adverse cardiac and cerebrovascular events (MACCE) 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. MACCE is defined as a combined event of in-hospital mortality, stroke and myocardial infarction.


Other Outcome Measures:
  1. All-cause mortality [ Time Frame: During one-year follow up ]
    All-cause mortality

  2. Cardiac-related mortality [ Time Frame: During one-year follow up ]
    Cardiac-related mortality

  3. Myocardial infarction [ Time Frame: During one-year follow up ]
    Myocardial infarction

  4. Stroke [ Time Frame: During one-year follow up ]
    Stroke

  5. Congestive heart failure requiring hospitalization [ Time Frame: During one-year follow up ]
    Congestive heart failure requiring hospitalization

  6. Surgical or percutaneous coronary intervention [ Time Frame: During one-year follow up ]
    Surgical or percutaneous coronary intervention

  7. Incidence of major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: During one-year follow up ]
    Incidence of major adverse cardiac and cerebrovascular events (MACCE)

  8. Correlation between intraoperative flow measurements and incidence of early bypass occlusion [ Time Frame: Day 0 to discharge date (max 10 days) ]
    Correlation between intraoperative flow measurements and incidence of early bypass occlusion

  9. Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period [ Time Frame: Day 0 to discharge date (max 10 days) ]
    Changes in ECG (= changes in the ST segment), prone for myocardial ischemia, during in-hospital period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who will undergo isolated coronary bypass surgery at the University Hospital Basel.
Criteria

Inclusion Criteria:

  • patients with isolated coronary bypass surgery

Exclusion Criteria:

  • Patients withholding or lacking informed consent
  • Patients requiring a concomitant procedure
  • Exclusion criteria concerning the CCT scan
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595630


Contacts
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Contact: Denis Berdajs, Prof. Dr. med. +41 61 328 71 80 denis.berdajs@usb.ch

Locations
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Switzerland
Department for Cardiac Surgery, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Denis Berdajs, Prof. Dr. med.    +41 61 328 71 80    denis.berdajs@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Denis Berdajs, Prof. Dr. med. Department of Cardiac Surgery, University Hospital Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04595630    
Other Study ID Numbers: 2020-02257; ch20Berdajs
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
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
Additional relevant MeSH terms:
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Graft Occlusion, Vascular
Postoperative Complications
Pathologic Processes