PRIMARY: postoperative biomarker measurements after coronary bypass surgery; towards an improved understanding and definition of the concepts of periprocedural myocardial injury and infarction

PRIMARY: postoperative biomarker measurements after coronary bypass surgery; towards an improved understanding and definition of the concepts of periprocedural myocardial injury and infarction - PRIMARY

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56115

Enrollment

143

Registered

2023-12-08

Start date

2024-04-16

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprocedural myocardial injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult patients (>18 years of age). - Surgery preceded by a heart-team discussion, in which the patient is planned for multivessel CABG, receiving more than one graft (i.e., more than only left internal mammary artery [LIMA] to left anterior descending artery [LAD]). - Isolated on-pump planned multivessel CABG (defined as using cardiopulmonary bypass and cardioplegic arrest). - Able and willing to provide written informed consent. - Elective or urgent surgery (defined as either planned surgery, or a surgical procedure without which the patients cannot leave the hospital before the surgery is performed24).

Exclusion criteria

Exclusion criteria: - Non-adult patients (

Design outcomes

Primary

Measure	Time frame
1. The diagnostic accuracy of the various assessed cardiac biomarkers for objectively quantified new myocardial cell necrosis on CMR at one month follow-up, in relation to the pre-operative baseline CMR imaging results. The area under the ROC curve will be used as the main diagnostic accuracy parameter. 2. The prognostic value of the various assessed cardiac biomarkers for the incidence of 1-year clinically relevant outcomes (defined as mortality, myocardial infarction, and/or unplanned revascularisation). The prognostic value of cardiac biomarkers will be compared using hazard ratios with 95% confidence intervals derived from multivariable Cox regression models.	—

Measure

Time frame

1. The diagnostic accuracy of the various assessed cardiac biomarkers for objectively quantified new myocardial cell necrosis on CMR at one month follow-up, in relation to the pre-operative baseline CMR imaging results. The area under the ROC curve will be used as the main diagnostic accuracy parameter. 2. The prognostic value of the various assessed cardiac biomarkers for the incidence of 1-year clinically relevant outcomes (defined as mortality, myocardial infarction, and/or unplanned revascularisation). The prognostic value of cardiac biomarkers will be compared using hazard ratios with 95% confidence intervals derived from multivariable Cox regression models.

—

Secondary

Measure	Time frame
- The diagnostic accuracy of the continuous visual and functional coronary CTA measurements will be assessed using the area under the ROC curve (AUC) as primary parameter. The test results of invasive coronary angiography will be used as reference standard. Presence of severe coronary stenosis based on the invasive coronary angiography will be defined as a visual stenosis of >70% and a fractional flow reserve (FFR) of	—

Measure

Time frame

- The diagnostic accuracy of the continuous visual and functional coronary CTA measurements will be assessed using the area under the ROC curve (AUC) as primary parameter. The test results of invasive coronary angiography will be used as reference standard. Presence of severe coronary stenosis based on the invasive coronary angiography will be defined as a visual stenosis of >70% and a fractional flow reserve (FFR) of

—

Countries

Netherlands

Outcome results