Duke University

Other

Robert M Califf

Robert H Christenson

Kristina N Sigmon

E Magnus Ohman

Harry P Selker

Trevor D Thompson

L Kristin Newby

Mary Ann O'Hanesian

W Douglas Weaver

Galen S Wagner

Robin T Vollmer

Magnus E Ohman

Show-Hong Duh

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.

Methods for evaluating therapies and predicting clinical outcome related to coronary conditions

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.

Method of assessing reperfusion after thrombolytic therapy

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 three 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. In a preferred embodiment of the present invention, the second and third 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 fourth variable reflecting the time from onset of chest pain to the beginning of thrombolytic therapy is included in the regression model.

An instrument for predicting the benefit of using thrombolytic therapy to treat a patient with a heart condition including a first input port for receiving inputs derived from electrocardiograph measurements of the patient's condition, and a processor for computing an estimate of said benefit based upon the electrocardiograph-derived inputs.

Thrombolysis predictive instrument

Growing community of inventors

Durham, NC, United States of America

Robert M Califf