Claims for Patent: 6,461,875

Summary for Patent: 6,461,875

Title:	Test for rapid evaluation of ischemic states and kit
Abstract:	The present invention relates to a rapid method for the detection of ischemic states and to a kit for use in such a method. Provided for is a rapid method of testing for the existence of and quantifying ischemia based upon method of detecting and quantifying the existence of an alteration of the serum protein albumin which occurs following an ischemic event; methods for detecting and quantifying this alteration include evaluating and quantifying the cobalt binding capacity of circulating blood, analysis and measurement of the ability of serum albumin to bind exogenous cobalt, detection and measurement of the presence of copper in a purified albumin sample and use of an immunological assay sepcific to the alterated form of serum albumin which occurs following an ischemic event. Also taught by the present invention is the use of the compound Asp-Ala-His-Lys-R, wherein R is any chemical group capable of being detected when bound to any compound capable of binding to the N-terminus of naturally occurring human albumin (including no additional chemical group), for detection and quantification of an ischemic event.
Inventor(s):	Bar-Or; David (Englewood, CO), Lau; Edward (Boulder, CO), Winkler; James V. (Denver, CO)
Assignee:	Ischemia Technologies, Inc. (Arvada, CO)
Application Number:	09/165,926
Patent Claims:	1. A method for detecting the occurrence or non-occurrence of an ischemic event in a patient comprising the steps of: (a) detecting the quantity of copper ions present in a purified albumin sample from said patient, and (b) assessing whether the quantity of copper ions present exceeds a known value whereby the occurrence or non-occurrence of an ischemic event may be determined. 2. The method of claim 1, the quantity of copper ions is measured by atomic absorption or atomic emission spectroscopy. 3. The method of claim 1, wherein said detecting step is performed using an immunological assay. 4. The method of claim 3, wherein said immunological assay is performed using an antibody specific to an antigen comprising the compound Asp-Ala-His-Lys-R, wherein R is copper. 5. The method of claim 1, wherein said patient possesses one or more cardiac risk factors, said cardiac risk factors being selected from the group consisting of: age greater than 50, history of smoking, diabetes mellitus, obesity, high blood pressure, high cholesterol, and strong family history of cardiac disease. 6. The method of claim 1, wherein the patient possesses one or more cardiac risk factors, further comprising: (a) following a first application of the method of claim 1, subjecting said patient to an exercise treadmill test followed by a second application of the method of claim 1; and (b) comparing the results of the two applications of the method of claim 1, whereby the occurrence or non-occurrence of an ischemic event may be determined. 7. The method of claim 1, wherein said ischemic event is a temporally-limited ischemic event. 8. A method of detecting the existence of ischemia in an asymptomatic patient comprising the method of claim 1. 9. A method of detecting the existence of ischemia in an asymptomatic patient comprising the method of claim 6. 10. The method of claim 3, wherein said immunological assay is conducted using an antibody to modified human serum albumin, said human serum albumin having been modified by mixture with copper ions. 11. The method of claim 10, wherein said antibody possesses known fluorescent properties. 12. The method of claim 1, wherein said detection method is used for diagnosis of a clinical condition selected from the group consisting of cardiac ischemia, brain ischemia and placental ischemia.

Details for Patent 6,461,875

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2040-01-28
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2040-01-28
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2040-01-28
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2040-01-28
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2040-01-28
Csl Behring Llc	ALBUMINAR, ALBUMINAR-20, ALBUMINAR-25, ALBUMINAR-5	albumin (human)	Injection	103955	03/17/2000		2040-01-28