'Non-ST-elevation Myocardial Infarction
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Acute onset chest pain (or angina pectoris equivalent) suspected of non-ST-elevation myocardial infarction (NSTEMI) • Hs-cTnT levels meeting the *observe* criteria (defined in the 2020 ESC Guidelines) • Hospital admission and scheduling for ICA (based on clinical judgement) • Age between 18 years - 85 years old • Written informed consent
Exclusion criteria
Exclusion criteria: • Symptoms highly suggestive of non-cardiac origin at presentation (as judged by the cardiac ED physician/cardiologist) or highly suggestive of AAD, PE, or acute peri-myocarditis (unless this has been ruled out using additional diagnostic testing) • Suspected type II MI: e.g. secondary to anemia (<5.6 mmol/L), untreated hyperthyroidism, severe hypertension (>200/110 mmHg), moderate or severe mitral/aortic valve stenosis by latest echocardiography • Atrial fibrillation or ongoing tachycardia (>=100/bpm) • Safety: indication for urgent or immediate ICA: e.g. hemodynamic unstable patients, life threatening arrhythmias, ST-elevation MI, heart failure requiring intravenously medication, refractory angina or on-going severe ischemia • Logistics: Inability to organize CMR and CT early after admission (especially for patients admitted on Friday evenings/nights • History: prior CABG, recent PCI (<6 months), recent myocardial infarction (<6 months), or known CAD not suitable for further interventions (PCI or CABG) • Pregnancy or breast feeding women • Life expectancy <1 year (malignancy, etc.) • Contraindications to CMR or CT: o Metallic implant (vascular clip, neuro-stimulator, cochlear implant) o Pacemaker or implantable cardiac defibrillator (ICD) o Claustrophobia o Body weight >130 kg or BMI > 35 or body habitus that does not fit into the gantry o Renal failure (estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1,73m2) o Known severe allergy to gadolinium or iodine contrast agents (patient with mild allergy is eligible for inclusion when pre-medication according to hospital guidelines can be administered) • Contraindications to adenosine: o High degree atrio-ventricular block (2nd or 3rd degree) o Severe bronchial asthma or recent exacerbation o Chronic obstructive pulmonary disease GOLD * III o Concomitant use of Dipyridamole (Persantin®) o Long QT syndrome (congenital) o Unable to refrain from caffeine >=12 hours prior to the examination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the sensitivity of CMR to detect obstructive CAD using ICA as gold standard in patients with suspected NSTEMI meeting the *observe* criteria and who are scheduled for ICA. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The diagnostic accuracy of CT to detect obstructive CAD using ICA as gold standard • The diagnostic accuracy of CMR, CT and ICA to detect a non-ST elevation acute coronary syndrome and differentiate non coronary causes for elevated troponin • The true incidence of coronary, non-coronary and extracardiac pathology by a comprehensive (non-)invasive pathway • The association between CMR, CT and ICA findings, and MACE, a composite of MACE, and major non cardiac adverse events after 30 days and one year • The hypothetical cost-effectiveness of an early discharge strategy based on a CMR or CT first approach versus a routine invasive strategy • The clinical benefit of CMR and/or CT when added to the diagnostic process in finding the diagnosis and patient management • The ability of identifying the culprit coronary artery with CMR, CT and ICA • To correlation of quantitative perfusion methods: CMR perfusion vs CT perfusion (rest) vs CT-FFR vs intracoronary ICA measurements • To assess the clinical value of CT and/or CMR (eg. change in clinical diagnosis, indication for revascularization, patient management [medication]) | — |
Countries
Netherlands
Outcome results
None listed