Cardiac Magnetic Resonance and Computed Tomography First in Suspected Non-ST-Elevation Myocardial Infarction. An Observational Two-Center Study
- Conditions
- 'Non-ST-elevation Myocardial Infarction'Myocardial Infarction'10011082
- Registration Number
- NL-OMON54580
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 127
• 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
• 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the sensitivity of CMR to detect obstructive CAD using<br /><br>ICA as gold standard in patients with suspected NSTEMI meeting the *observe*<br /><br>criteria and who are scheduled for ICA.</p><br>
- Secondary Outcome Measures
Name Time Method