Identification of Culprit Lesions in Non ST-elevation Myocardial Infarction and Multivessel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)
研究概览
简要总结
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. In patients with a partial occlusion and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination (coronary angiogram, CAG) can be difficult.
Meanwhile, identification of the culprit lesion is vital to conduct proper treatment. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. Precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled
The purpose of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.
详细描述
Background
Acute myocardial infarction owes to a plaque rupture resulting in total (STEMI) or partial occlusion (NSTEMI) of the coronary artery. Current guidelines in NSTEMI recommend an invasive coronary angiogram (CAG) and possible treatment with percutaneous intervention (PCI) within 2-72 hours. In NSTEMI patients and multi vessel disease (MVD), identification of the lesion responsible for the current event (culprit) at the time of the examination can be difficult.
Meanwhile, identification of the culprit lesion is vital to conduct proper treatment in order to restore blood flow to the myocardium. Furthermore, treating an artery with no plaque rupture (non-culprit), imposes a small risk for complications, which may be fatal. In addition, since the symptoms relate to the culprit lesion it is currently unclear whether all stenosis or only the culprit should be treated by PCI. Today precise identification of the culprit lesion in NSTEMI patients with MVD remains unsettled.
Purpose
The overall objective of this study is proper and precise identification of the culprit lesion in NSTEMI patients with MVD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •NSTEMI (ECG changes and/or troponin/creatine kinase myocardial band (CK-MB) rise) within 48 hours after symptom debut.
- •Multivessel disease at CAG: More than one vessel with >50% stenosis.
排除标准
- •Known intolerance of heparin or contrast medium.
- •Inability to understand information or to provide informed consent.
- •estimated glomerular filtration rate (eGFR) < 30 ml/min.
- •Other reasons for troponin rise not applicable to acute myocardial infarction.
- •Atrial fibrillation at admission.
- •Patients with contraindication for CMR will only have OCT performed.
- •Potential pregnancy
- •Unstable patients requiring acute CAG and PCI
结局指标
主要结局
Is the PCI operator capable of identifying the culprit lesion based on ECG-changes and CAG? (CMR is the golden standard)
时间窗: Through study completion, an average of 1 year
Correlation between operator identification of the culprit and CMR/OCT. The location of the culprit on CAG/ECG and OCT versus CMR will be evaluated by the chi2-test
次要结局
- Improvement in identification of culprit lesions evaluated by identification of an additional diagnostic value of OCT compared to CAG/ECG(Through study completion, an average of 1 year)
- Positive predictive value of PCI operator identification of culprit lesion with CAG and ECG.(Through study completion, an average of 1 year)
研究者
Thomas Engstrom
Professor
Rigshospitalet, Denmark