NCT02563964终止不适用
Characterizing Vulnerable Plaques in Non-ST-Elevation Myocardial Infarction Using 18F-NaF Positron Emission Tomography - Cardiac Magnetic Resonance Imaging: A Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
Myocardial infarction (MI) frequently recurs after non-ST elevation MI (NSTEMI) that may be related to insufficient vulnerable plaque identification using invasive coronary angiography. Furthermore, the natural behaviour of vulnerable plaques in NSTEMI over time and their relation with biomarkers need further exploration. More accurate identification and assessing long-term behaviour of vulnerable plaques may improve therapeutic strategies and clinical outcome. The investigators hypothesize that fully integrated 18Fluoride Sodium-Fluoride (18F-NaF) Positron Emission Tomography/Cardiac Magnetic Resonance imaging (PET/CMR) increases the ability to detect vulnerable plaques as compared to coronary angiography.
This prospective study in 33 consecutive patients with NSTEMI aims to:
- Compare coronary vulnerable plaque detection between 18F-NaF PET/CMR and invasive coronary angiography,
- Investigate the correlation of coronary vulnerable plaques using 18F-NaF PET with myocardial infarction using CMR, both at baseline and during follow-up,
- Examine systemic arterial 18F-NaF-uptake using PET/CMR and their relation with systemic events (cerebrovascular accidents, transient ischemic attacks, or peripheral arterial disease), and
- Examine the relation between vulnerable plaques and plasma biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: 0 to 6 months
The frequency of coronary vulnerable plaques in NSTEMI using routine invasive coronary angiography.
时间窗: 0 to 6 months
次要结局
- Serial serum concentrations of biomarkers of plaque vulnerability and myocardial injury at baseline and follow-up.(0 to 6 months)
- The location of vulnerable plaques within the coronary arteries using 18F-NaF PET at baseline and follow-up.(0 to 6 months)
- The frequency of systemic vulnerable plaques as assessed with 18F-NaF PET/CMR at baseline and follow-up.(0 to 6 months)
- Based on the AHA 17-segment model, the segmental location of MI using CMR at baseline and follow-up.(0 to 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Culprit Lesions in NSTEMI With Multi Vessel Disease (NSTEMI-CULPRIT)NSTEMI - Non-ST Segment Elevation MIMulti Vessel Coronary Artery DiseaseNCT03479593Rigshospitalet, Denmark100
已完成
4 期
Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMINSTEMINCT01159366University of Jena602
已完成
不适用
Initial CT Perfusion-Guided Strategy for Suspected NSTEMINon-ST Elevation Myocardial InfarctionNCT06689267Shanghai Zhongshan Hospital180
尚未招募
不适用
(Non-)ST-elevation myocardial infarction and Multivessel coronary Artery disease: coronary Resistance guided multivessel Treatment.coronary artery diseasecoronary sclerosis10011082NL-OMON34491Academisch Medisch Centrum300
Unknown
4 期
Fractional Flow Reserve Versus Angiographically Guided Management to Optimise Outcomes in Unstable Coronary SyndromesNonST Elevation Myocardial InfarctionMyocardial InfarctionNCT01764334NHS National Waiting Times Centre Board350