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NCT Number: NCT04595630

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

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.

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Key information

Conditions

Coronary Bypass Graft Occlusion Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Centre Zagreb, Zagreb, Croatia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

data collection from the hospital records

Other

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.

Primary outcomes

  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 outcomes

  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 outcomes

  1. All-cause mortality

    Time frame: During one-year and 36 months follow up

    All-cause mortality

  2. Cardiac-related mortality

    Time frame: During one-year and 36 months follow up

    Cardiac-related mortality

  3. Myocardial infarction

    Time frame: During one-year and 36 months follow up

    Myocardial infarction

  4. Stroke

    Time frame: During one-year and 36 months follow up

    Stroke

  5. Congestive heart failure requiring hospitalization

    Time frame: During one-year and 36 months follow up

    Congestive heart failure requiring hospitalization

  6. Surgical or percutaneous coronary intervention

    Time frame: During one-year and 36 months follow up

    Surgical or percutaneous coronary intervention

  7. Incidence of major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: During one-year and 36 months 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

Study contacts

Contact information is provided by the study sponsor or research team.

Denis Berdajs, Prof. Dr. med.

CONTACT

[email protected]

+41 61 328 71 80

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Oct 20, 2020
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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