Kits for early detection of heart disease

• US 6,534,322 B1
• Filed: 01/21/2000
• Issued: 03/18/2003
• Est. Priority Date: 06/10/1997
• Status: Expired due to Term

• Current Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Original Assignee: Medlyte Diagnostics, Inc.
• Inventors: Sabbadini, Roger A.
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US09/489,158
• Time in Patent Office: 1,152 Days
• Field of Search: 435/7.1, 435/7.92, 435/810, 435/967, 435/975, 436/71, 436/63, 436/518, 436/536, 436/541, 436/161, 436/162, 436/173, 436/808, 530/412, 530/413, 530/417
• US Class Current: 436/518
• CPC Class Codes: G01N 2405/08 Sphingolipids
• CPC Class Codes: G01N 2800/32 Cardiovascular disorders
• CPC Class Codes: G01N 2800/325 Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/967 Standards, controls, materials, e.g. validation studies, buffer systems
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds
• CPC Class Codes: Y10T 436/24 Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry

Abstract

The invention relates to methods, compositions, kits, and devices for detecting cardiac ischemia, hypoxia, or other causes of heart failure in a mammal by obtaining a test sample from a mammal, measuring a level of a non-polypeptidic cardiac marker in the test sample, and determining if the level of the cardiac marker measured in said test sample correlates with cardiac ischemia or hypoxia or another form of heart failure.

Claims

1. A kit for detecting a condition which causes heart disease in a mammal, the kit comprising a composition for detecting a level of at least one non-polypeptidic cardiac marker in a test sample obtained from said mammal, wherein said kit is able to determine if said level of said non-polypeptidic cardiac marker in said test sample correlates with said condition that causes heart disease in a mammal wherein said marker is selected from the group consisting of sphingolipid, sphingosine, sphingosine-1-phosphate, dihydrosphingosine and sphingosylphosphorylcholine.

2. A kit according to claim 1 wherein said level of at least one non-polypeptidic cardiac marker is measured quantitatively.

3. A kit according to claim 1 wherein said composition comprises a substrate.

4. A kit according to claim 3 wherein said substrate is an antibody which binds specifically to a non-polypeptidic cardiac marker.

5. A kit according to claim 3 wherein said substrate is an antibody which binds specifically to a sphingolipid.

6. A kit according to claim 1 wherein said kit comprises one or more standards having a predetermined level of a non-polypeptidic cardiac marker.

7. A kit according to claim 6, wherein said kit comprises two or more standards, wherein at least two of said standards have different levels of said non-polypeptidic cardiac marker.

8. A kit according to claim 7 wherein said kit comprises instructions for comparing the level of said non-polypeptidic cardiac marker in said test sample to the level of at least one non-polypeptidic cardiac marker in said two or more standards.

9. A kit according to claim 1 wherein said kit comprises a composition or device for obtaining a test sample using an invasive method.

10. The kit according to claim 1 further comprising a composition for measuring the level of a second marker.

11. The kit according to claim 10 wherein said second marker is a pro-inflammatory cytokine.

12. The kit according to claim 11 wherein said pro-inflammatory cytokine is TNFα

.

13. A method of using the kit of claim 1 to detect a condition which causes heart disease in a mammal.

14. The kit of claim 1 wherein said heart disease is selected from the group consisting of heart failure, cardiac ischemia and cardiac hypoxia.

15. The kit of claim 14 wherein said heart failure is selected from the group consisting of acute myocardial infarction, myocarditis, a cardiomyopathy, congestive heart failure and idiopathic heart failure.

16. The kit of claim 1 wherein said mammal is a human.