The supplementary role of cardiovascular magnetic resonance imaging and computed tomography angiography to routine clinical practice in suspected non-ST elevation myocardial infarction. A randomized controlled trial.
- Conditions
- Non-ST elevation myocardial infarction - Heart attack10028593
- Registration Number
- NL-OMON43969
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 207
*Prolonged symptoms suspected of cardiac origin (angina pectoris or angina
equivalent), and presentation on the cardiac ED <24 hours after symptom onset
*Increased highly sensitive troponin-T level (hs-TnT *0.014*g/L) (initial blood sample at presentation or a second sample *3 hours after presentation)
*Age 18 years * 85 years
*Willing and capable to give written informed consent
*Written informed consent
*Ongoing severe ischemia requiring immediate ICA (at discretion of cardiac ED
physician/cardiologist)
*Shock (mean arterial pressure < 60 mmHg) or 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):
o Acute aortic dissection
o Acute pulmonary embolism (high risk patient defined as Wells score >6)
o Musculoskeletal or gastro-intestinal pain
o Other (pneumothorax, pneumonia, rib fracture, etc.)
*Previously known coronary artery disease (CAD), defined as:
o Any non-invasive diagnostic imaging test positive for CAD (perfusion defects, and/or stress induced wall motion abnormalities)
o Coronary stenosis >50% on any previous ICA or CTA
o Documented previous myocardial infarction
o Documented previous coronary artery revascularization (PCI and/or CABG)
*Known cardiomyopathy (dilated, hypertrophic, infiltrative, etc.)
*Pregnancy
*Life threatening arrhythmia 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
*Tachycardia (*100/bpm) induced angina pectoris
*Angina pectoris secondary to anemia (<5.6 mmol/L), untreated hyperthyroidism, aortic valve stenosis (AVA * 1.5 cm2), or severe hypertension (>200/110 mmHg)
*Life expectancy <1 year (malignancy, etc.);*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;*Contraindication to CMR or CTA contrast agent (Gadolinium or Iodine):
ODIN protocol: *Voorbereiding bij contrastonderzoeken of -interventies met intravasculair gebruik van jodiumhoudende contrastmiddelen; voorkomen van contrastnefropathie, CIN, hydratieschema*
o Renal failure (estimated GFR *30 mL/min/1,73m2) / chronic renal failure stage 4-5 (details for
CTA arm in appendix D: detailed CTA protocol)
o Known severe contrast allergy (patient with mild allergy is eligible for inclusion
when pre-medication according to hospital guidelines can be administered);*Contraindication to adenosine:
o High degree atrio-ventricular block (2nd or 3rd degree)
o Severe asthma bronchiale
o Chronic obstructive pulmonary disease Gold * III
o Concomitant use of dipyridamole (Persantin)
o Long QT syndrome (congenital)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Total number of patient with at least one ICA during the initial admission</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/outcome<br /><br>*Thirty-day clinical outcome (MACE)<br /><br>*Composite of one-year clinical outcome (MACE) and major adverse events<br /><br>*Time to final diagnosis (in days)<br /><br>*Number of CCA that can be identified in patients with a final diagnosis of MI<br /><br>*Quality of life<br /><br>*Cost-effectiveness<br /><br><br /><br>Tertiary study parameters/outcome:<br /><br>*The total number of patients with a coronary etiology correctly identified by<br /><br>cardiogoniometry<br /><br>*Preferences of patients for attributes of CTA and CMR</p><br>