Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction using PET-CMR: A Feasibility Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

* Prolonged symptoms suspected of cardiac origin (angina pectoris or angina equivalent), and presentation on the cardiac ED <24 hours after symptom onset
* Increased levels of hs-TnT (>14ng/L) (initial blood sample at presentation or a second sample)
* 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 (ICA)
* Patients requiring invasive coronary angiography (ICA) < 24 hours after admission
* Hemodynamic instability and cardiogenic shock (mean arterial pressure < 60 mmHg)
* Severe heart failure (Killip Class * III)
* STEMI (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 ED physician/cardiologist):
* (Suspicion of) acute aortic dissection, acute pulmonary embolism, acute peri-myocarditis
* Life threatening arrhythmias on the cardiac ED 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.)
* Participation in another investigational study that has not reached its primary endpoint
* Contraindications to CMR:
ODIN protocol: *Uitvoering van MRI onderzoek bij patiënten met een cardiaal implanteerbaar elektronisch device (CIED), waaronder een pacemaker en ICD*
ODIN protocol: *Voorbereiding klinische patiënten voor MRI onderzoek*
o Metallic implant (vascular clip, neuro-stimulator, cochlear implant)
o Pacemaker or implantable cardiac defibrillator (ICD)
o Claustrophobia
o Body weight >130 kg or body habitus that does not fit intro the gantry
o Renal failure (estimated GFR *30 mL/min/1,73m2) / chronic renal failure stage 4-5
o Known severe allergy to gadolinium contrast agents (patient with mild allergy is eligible for inclusion when pre-medication according to hospital guidelines can be administered)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The frequency of coronary vulnerable plaques in patients with NSTEMI as<br /><br>assessed with 18F-NaF-PET-CMR and routine invasive coronary angiography.<br /><br>Vulnerable plaques will be operationalized as present/absent, and if detected,<br /><br>additionally as a count variable, i.e. numbers of vulnerable plaques per<br /><br>patient.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The distribution (location) of coronary vulnerable plaques using 18F-NaF-PET<br /><br>and the location of myocardial infarction using CMR at baseline and follow-up<br /><br>(* 6 months). We hypothesize that the hybrid imaging will enable a<br /><br>juxtaposition of the location(s) of vulnerable coronary artery with the<br /><br>presence/location of scar.<br /><br>* The frequency and distribution of systemic (carotid) vulnerable plaques as<br /><br>assessed with 18F-NaF-PET-CMR at baseline and follow-up (* 6 months).<br /><br>* The frequency of clinical systemic arterial events (cerebrovascular accidents<br /><br>(CVA), transient ischemic attacks (TIA, including amaurosis fugax), peripheral<br /><br>arterial embolism, or progressive peripheral occlusive arterial disease<br /><br>peripheral arterial disease) during one year.<br /><br>* Serial serum concentrations of biomarkers of plaque vulnerability and<br /><br>myocardial injury at baseline and follow-up (* 6 months).</p><br>