NL-OMON54580
Recruiting
Not Applicable
Cardiac Magnetic Resonance and Computed Tomography First in Suspected Non-ST-Elevation Myocardial Infarction. An Observational Two-Center Study - CMR-CT-OBSERVE
Medisch Universitair Ziekenhuis Maastricht0 sites127 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Enrollment
- 127
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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