Method of assessing reperfusion after thrombolytic therapy

• US 6,033,364 A
• Filed: 11/07/1997
• Issued: 03/07/2000
• Est. Priority Date: 08/17/1995
• Status: Expired due to Fees

• Current Assignee: Duke University
• Original Assignee: Duke University
• Inventors: Sigmon, Kristina N., O'Hanesian, Mary Ann, Califf, Robert M., Ohman, E. Magnus, Christenson, Robert H.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US08/966,848
• Time in Patent Office: 851 Days
• Field of Search: 600/300, 600/301, 600/481, 600/483, 128/898
• US Class Current: 600/300
• CPC Class Codes: C12Q 1/50 involving creatine phosphokinase
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof

Abstract

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.

Claims

1. A method of determining if reperfusion has occurred in a myocardial infarct patient after receiving thrombolytic therapy, comprising:

(a) detecting a first variable comprising a first serum creatine kinase MB level in a myocardial infarct patient undergoing thrombolytic therapy at the an onset of said thrombolytic therapy;

then

(b) detecting a second variable comprising a second creatine kinase MB level in said patient a predetermined time after the onset of said thrombolytic therapy; and

(c) detecting a third variable comprising a presence or absence of chest pain a predetermined time after the onset of said thrombolytic therapy;

(d) detecting a fourth variable comprising a serum myoglobin level in said patient a predetermined time after the onset of said thrombolytic therapy;

(e) generating a probability of the presence of a persistent occlusion from said first through fourth variables, the absence of a persistent occlusion indicating that reperfusion has occurred in said patient.

2. A method according to claim 1, wherein said second variable, said third variable and said fourth variable are detected within thirty minutes of one another, and wherein said second variable, said third variable and said fourth variable are detected from 1 to 3 hours after the onset of thrombolytic therapy.

3. A method according to claim 1, wherein said second variable, said third variable and said fourth variable are detected concurrently one and one-half hours after the onset of thrombolytic therapy.

4. A method according to claim 1, further comprising the step of:

determining a fifth variable comprising a time from onset of myocardial infarct symptoms in said patient to an administration of the thrombolytic therapy to said patient,

and wherein said generating step comprises generating the probability of the presence of a persistent occlusion from said first through fifth variables.

5. A method according to claim 1, wherein said generating step is carried out with an empirically-based model of actual clinical experience.

6. A method according to claim 5, further comprising the step of updating said empirically-based model to include the clinical experience of said myocardial infarct patient.

7. A method according to claim 1, wherein said generating step is carried out with a regression model.

8. A method according to claim 1, wherein said first variable is detected within about 6 hours from an onset of symptoms in the patient and within about 1 hour of the onset of thrombolytic therapy.

9. A method of determining if reperfusion has occurred in a myocardial infarct patient after receiving thrombolytic therapy, comprising:

(a) detecting a first variable comprising a first serum creatine kinase MB level in a myocardial infarct patient undergoing thrombolytic therapy at an onset of said thrombolytic therapy;

then

(b) detecting a second variable comprising a second creatine kinase MB level in said patient a predetermined time after the onset of said thrombolytic therapy; and

(c) detecting a third variable comprising a presence or absence of chest pain a predetermined the after the onset of said thrombolytic therapy;

(d) detecting a fourth variable comprising a serum myoglobin level in said patient a predetermined time after the onset of said thrombolytic therapy;

(e) detecting a fifth variable comprising a time from onset of myocardial infarct symptoms in said patient to an administration of the thrombolytic therapy to said patient;

(f) generating a probability of the presence of a persistent occlusion from said first through fifth variables, the absence of a persistent occlusion indicating that reperfusion has occurred in said patient;

wherein said first variable is detected within about 6 hours from an onset of symptoms in the patient and within about 1 hour of the onset of thrombolytic therapy;

wherein said second variable, said third variable and said fourth variable are detected within thirty minutes of one another;

and wherein said second variable, said third variable and said fourth variable are detected from 1 to 3 hours after the onset of thrombolytic therapy.

10. A method according to claim 9, wherein said second variable, said third variable and said fourth variable are detected concurrently one and on-half hours after the onset of thrombolytic therapy.

11. A method according to claim 9, wherein said generating step is carried out with an empirically-based model of actual clinical experience.

12. A method according to claim 11, further comprising the step of updating said empirically-based model to include the clinical experience of said myocardial infarct patient.

13. A method according to claim 9, wherein said generating step is carried out with a regression model.