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

Conditions: Periprocedural myocardial injury
10011082

Registration Number: NL-OMON56115

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 143

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

- Non-adult patients (<18 years of age)
- Emergency surgery (defined as within 24 hours of indication and not waiting
until the following working day24).
- Recent acute coronary syndromes (including ST-elevation myocardial infarction
[STEMI] and non-STEMI [NSTEMI], recent defined as <14 days prior to surgery).
- Patients with contraindications to undergo cardiac magnetic resonance imaging
(including claustrophobia and CMR-incompatible implants).
- Prior adverse reactions to gadolinium- or iodine-based contrast agents.
- Moderate-severely compromised renal function (estimated glomerular filtration
[eGFR] <45mL/min/kg)
- In clinical heart failure upon admission for surgery.
- Pregnant or breast-feeding patients

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures