NL-OMON43969已完成不适用
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. - Non-invasive imaging in suspected NSTEMI CARMENTA trial
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 207 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*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
排除标准
- •*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)
研究者
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