Vulnerable Plaque Imaging in NSTEMI
Mots clés
Abstrait
Rendez-vous
| Dernière vérification: | 02/29/2020 |
| Première soumission: | 09/24/2015 |
| Inscription estimée soumise: | 09/27/2015 |
| Première publication: | 09/29/2015 |
| Dernière mise à jour soumise: | 03/09/2020 |
| Dernière mise à jour publiée: | 03/11/2020 |
| Date de début réelle de l'étude: | 08/31/2017 |
| Date d'achèvement primaire estimée: | 03/09/2020 |
| Date estimée d'achèvement de l'étude: | 03/09/2020 |
Condition ou maladie
Phase
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Méthode d'échantillonnage | Probability Sample |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: - Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac emergency department <24 hours after symptom onset - Elevated levels of high-sensitivity troponin T (>14ng/L; initial blood sample at presentation or a second sample 3 hours after presentation) - Only patients scheduled for invasive coronary angiography - Age 18 years - 85 years - Mentally competent - Informed written consent Exclusion Criteria: - Conservatively managed patients who are not scheduled for invasive coronary angiography - Refractory angina or on-going severe ischemia requiring immediate invasive coronary angiography - Patients requiring invasive coronary angiography < 24 hours after admission - Hemodynamic instability and cardiogenic shock (mean arterial pressure < 60 mmHg) - Severe heart failure (Killip Class ≥ III) - ST elevation myocardial infarction (ST-elevation in 2 contiguous leads: ≥0.2mV in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new left bundle branch block) - Chest pain highly suggestive of non-cardiac origin (as judged by the cardiac emergency department physician/cardiologist): - (Suspicion of) acute aortic dissection, acute pulmonary embolism, acute peri-myocarditis - Life threatening arrhythmias on the cardiac emergency department or prior to presentation (sustained ventricular tachycardia, repetitive non-sustained ventricular tachycardia, ventricular fibrillation, sino-artial or atrio-ventricular block) - Atrial fibrillation with ventricular rate ≥100 beats per minute (bpm) - Tachycardia (≥100/bpm) - Angina pectoris secondary to anaemia (<5.6 mmol/L), untreated hyperthyroidism, or severe hypertension (>200/110 mmHg) - More than mild aortic and mitral valve calcification or stenosis by latest echocardiography - Pregnancy - Breast feeding women - Life expectancy <2 years (malignancy, etc.) - Refusal of data storage until 15 years after end of study - Participation in another investigational study that has not reached its primary endpoint - Contraindications to cardiac magnetic resonance imaging |
Résultat
Mesures des résultats primaires
1. The frequency of coronary vulnerable plaques in non-ST-elevation myocardial infarction (NSTEMI) using 18Fluoride Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance (PET/CMR). [0 to 6 months]
2. The frequency of coronary vulnerable plaques in NSTEMI using routine invasive coronary angiography. [0 to 6 months]
Mesures des résultats secondaires
1. The location of vulnerable plaques within the coronary arteries using 18F-NaF PET at baseline and follow-up. [0 to 6 months]
2. Based on the AHA 17-segment model, the segmental location of MI using CMR at baseline and follow-up. [0 to 6 months]
3. The frequency of systemic vulnerable plaques as assessed with 18F-NaF PET/CMR at baseline and follow-up. [0 to 6 months]
4. Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up. [0 to 6 months]
