公开(公告)号：US06662114B1

公开(公告)日：2003-12-09

申请号：US09642905

申请日：2000-08-21

申请人： Robert H. Christenson ,  Show-Hong Duh ,  Robin T. Vollmer ,  E. Magnus Ohman ,  Trevor D. Thompson ,  L. Kristin Newby ,  Robert M. Califf

发明人： Robert H. Christenson ,  Show-Hong Duh ,  Robin T. Vollmer ,  E. Magnus Ohman ,  Trevor D. Thompson ,  L. Kristin Newby ,  Robert M. Califf

IPC分类号： G01N3348

CPC分类号： C12Q1/50

摘要： A method for predicting the clinical outcome for a patient after the patient has received therapy for an acute coronary syndrome such as myocardial infarction comprises: (a) optionally, but preferably, detecting a first variable comprising a serum creatine kinase-MB release curve area in the patient after initiation of said therapy; (b) detecting a second variable comprising a serum creatine kinase-MB release curve maxima in the patient after initiation of said therapy; then (c) optionally, but preferably, detecting a third variable comprising the slope of the descending portion of the serum creatine kinase-MB release curve after initiation of said therapy (wherein a steep slope for said descending portion is a more favorable indicator of clinical outcome than a shallow slope); and (d) generating a prediction of clinical outcome for said patient from the variables collected above. The method is useful in conjunction with established therapies such as thrombolytic therapy, and is particularly useful as a surrogate end point in clinical trials of new potential therapies.

摘要翻译： 用于预测患者接受急性冠状动脉综合征如心肌梗死的治疗后患者的临床结果的方法包括：（a）任选地，但优选地，检测包含血清肌酸激酶-MB释放曲线区域的第一变量， 所述治疗开始后的患者; （b）在开始所述治疗之后检测患者中包含血清肌酸激酶-MB释放曲线最大值的第二变量; 然后（c）任选地，但优选地，检测包括在开始所述治疗之后血清肌酸激酶-MB释放曲线的下降部分的斜率的第三变量（其中所述下降部分的陡峭斜率是临床上更有利的指标 结果比浅坡）; 和（d）从上面收集的变量产生所述患者的临床结果的预测。 该方法与已有的疗法如溶栓治疗相结合，并且作为新的潜在疗法的临床试验中的替代终点是特别有用的。

公开(公告)号：US6033364A

公开(公告)日：2000-03-07

申请号：US966848

申请日：1997-11-07

申请人： E. Magnus Ohman ,  Robert H. Christenson ,  Robert M. Califf ,  Mary Ann O'Hanesian ,  Kristina N. Sigmon

发明人： E. Magnus Ohman ,  Robert H. Christenson ,  Robert M. Califf ,  Mary Ann O'Hanesian ,  Kristina N. Sigmon

IPC分类号： C12Q1/50 ,  G01N33/68 ,  G06F17/00 ,  G06F19/00 ,  A61B5/00

CPC分类号： C12Q1/50 ,  G01N33/6887 ,  G06F19/3487

摘要： The present invention is a method of diagnosing the presence of a persistent occlusion in a myocardial infarct patient undergoing thrombolytic therapy. The method comprises detecting a series of five variables from the patient and then generating the probability of the presence of a persistent occlusion from those variables. The first variable comprises a serum creatine kinase MB (CK-MB) level from a patient at the onset of thrombolytic therapy. The second variable comprises a second CK-MB level in the patient at a predetermined time after the onset of thrombolytic therapy. The third variable comprises the presence or absence of chest pain a predetermined time after the onset of thrombolytic therapy. The fourth variable comprises the serum myoglobin level in the patient at a predetermined time after the onset of thrombolytic therapy. In a preferred embodiment of the present invention, the second, third and fourth variables are detected within 30 minutes of each other and within about 1 to about 3 hours after the initial variable is detected. In an alternate embodiment a fifth variable reflecting the time from onset of chest pain to the beginning of thrombolytic therapy is included in the regression model.

摘要翻译： 本发明是诊断经历溶栓治疗的心肌梗死患者中持续性闭塞的存在的方法。 该方法包括从患者中检测一系列五个变量，然后从这些变量产生持续闭塞的存在概率。 第一个变量包括来自溶栓治疗开始时患者的血清肌酸激酶MB（CK-MB）水平。 第二变量包括在溶栓治疗开始之后的预定时间的患者中的第二CK-MB水平。 第三个变量包括在溶栓治疗开始后的预定时间内存在或不存在胸痛。 第四个变量包括在溶栓治疗开始之后的预定时间内患者的血清肌红蛋白水平。 在本发明的优选实施例中，第二，第三和第四变量在彼此之间的30分钟内被检测，并且在检测到初始变量之后约1至约3小时内。 在替代实施例中，回归模型中包括反映从胸痛发作到溶栓治疗开始的时间的第五个变量。