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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cardiac Biomarkers for the Quantification of Myocardial Damage After Cardiac Surgery

NCT06066970

Cardiac Valve Disease

RECRUITING

The Prognostic Value of Troponin T for Long-term Outcome After Cardiac Surgery

NCT00468598

Heart; Dysfunction Postoperative, Cardiac Surgery Adverse Anesthesia Outcome

COMPLETED

Prognostic Value of New Cardiac Biomarkers in Elderly Patients Undergoing Cardiac Surgery

NCT00416299

Cardiac Surgery

COMPLETED

Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery

NCT04250935

Cognitive Dysfunction

COMPLETED

Blood Transfusions in Coronary Artery Bypass Surgery

NCT02953951

Excessive Amount of Blood / Fluid Transfusion

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Bypass Graft Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with isolated coronary bypass surgery

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No