One-hour Diagnostic Algorithm for Non-ST Elevation Myocardial Infarction Based on Determination of Fatty-acid-binding Protein Concentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Fatty acid-binding protein (h-FABP) measure
研究概览
简要总结
Predictable values of the 1-hour algorithm for estimating the concentration of troponin using highly sensitive reagents are 98-100% for excluding myocardial infarction (MI) and 75-80% for identifying this pathology. Such algorithms are developed for the rapid confirmation or exclusion of myocardial infarction without ST-segment elevation and, when combined with clinical data and electrocardiogram, are used to assess the risk of adverse course of disease and to contribute to decision making about expediency of stay in the intensive therapy unit and early discharge.
In mid-1980s, a new marker of myocardial damage was proposed, namely: fatty-acid-binding protein (FABP). However, the diagnostic value of FABP cannot be interpreted unambiguously because of insufficient number of studies determining the sensitivity and specificity of the test in various manifestations of acute coronary syndrome (ACS).
Available literature presents a wide range of reference values of FABP for MI diagnosis. Reference value ranges are proposed by manufacturers of diagnostic kits based on previous studies. In addition, there is no information about the FABP changes during the first three hours of the disease, as well as there are no data on diagnostic value of changes in this indicator ("∆") in patients with ACS without ST-segment elevation. These considerations provide rationale and support novelty of the planned pilot study.
详细描述
After enrollment in the study, patients will undergo the following procedures:
- Physical examination (at baseline) and monitoring of vital signs (blood pressure, heart rate, breathing rate) at hours 1, 2, and 3 after admission to hospital.
- Registration of 12-lead electrocardiogram (ECG) (at baseline, after 24 hours, and at the day of discharge).
- At baseline (at the time of admission to hospital), venous blood will be obtained to perform blood tests for determination of troponin I, FABP, and CPK-MB levels. At the same time, venous blood will be sampled for routine clinical laboratory blood tests. At hours 1, 2, and 3 after admission to hospital, venous blood will be sampled for assessment of the troponin I and FABP levels.
- Echocardiography will be performed 24 hours after admission (LVEDV, LVESV, and EF). At day 3, standard echocardiography will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years old
- •Male patients
- •Acute pain in the chest similar to myocardial infarction with/or without ECG changes
- •Admission to the hospital within 4 hours from onset of the disease.
排除标准
- •Patients with ACS in the preceding 30 days
- •Cerebral blood circulation disorder
- •Recent surgical intervention
- •Extensive burns of degree 2-3
- •Massive wounds and injuries
- •Percutaneous coronary intervention or cardioversion
- •Pregnancy or lactation
- •Malignant tumors of stage 4
- •Severe renal insufficiency (GFR< 30 mL/min)
研究组 & 干预措施
FABP group
Coronary angiography and PCI (according to indications).
干预措施: FABP (Diagnostic Test)
结局指标
主要结局
Fatty acid-binding protein (h-FABP) measure
时间窗: At 4 hours after suspected NSTEMI onset
Establishing diagnosis of NSTEMI based on h-FABP test for early detection of myocardial infarction
次要结局
- Creatine phosphokinase-MB (CPK-MB) measure(At 4 hours after suspected NSTEMI onset)
- Troponin I (cTnI) measure(At 4 hours after suspected NSTEMI onset)
- Creatine phosphokinase (CPK) measure(At 4 hours after suspected NSTEMI onset)