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CN-122029432-A - Method for evaluating long-term high risk of cardiovascular and cerebrovascular/renal adverse events using soluble CLEC-2

CN122029432ACN 122029432 ACN122029432 ACN 122029432ACN-122029432-A

Abstract

The present invention provides a technique capable of accurately and simply predicting the long-term risk of occurrence of cardiovascular and cerebrovascular adverse events and renal adverse events. Further, by the above-described technique, a technique for selecting a therapeutic method for improving the benefit in prevention of a subject patient is provided. The technique evaluates the long-term high risk of developing cardiovascular/renal adverse events based on the concentration of soluble CLEC-2 in the blood of the subject.

Inventors

  • IKAI HIDEO
  • TSUBOI NAOKI
  • Kakenawa Hiroshi
  • ISHII KOICHI
  • Cheng cheng zhi
  • KAWAI HIDEAKI
  • Takehiko Kitagawa
  • MASAHIDE KAWAMURA

Assignees

  • 普和希株式会社

Dates

Publication Date
20260512
Application Date
20241004
Priority Date
20231006

Claims (15)

  1. 1. A method of assessing a high risk of developing cardiovascular/renal adverse events over a long period of time based on the concentration of soluble CLEC-2 in the blood of a subject.
  2. 2. The method of claim 1, which is a method of assessing the long-term high risk of developing cardiovascular/renal adverse events based on the concentration of soluble CLEC-2 in the blood of a subject, the method comprising: (1) Providing a blood sample from the subject; (2) A step of determining the concentration of soluble CLEC-2 in the sample; (3) And correlating the concentration of the soluble CLEC-2 with the likelihood of long-term onset of cardiovascular/renal adverse events in the subject.
  3. 3. The method according to claim 1 or 2, which is a method of long-term risk assessment of onset of a disease in which a subject is suspected of having or diagnosed with a risk of cardiovascular/renal adverse events.
  4. 4. A method according to any one of claims 1 to 3, wherein the disease at risk of cardiovascular/renal adverse events is selected from chronic kidney disease, diabetes, hypertension, dyslipidemia, chronic maintenance dialysis, arteriosclerotic diseases.
  5. 5. The method according to any one of claims 1 to 4, wherein the high risk of developing cardiovascular/renal adverse events over a long period is evaluated based on the concentration of D-dimer in the blood of the subject in addition to the concentration of soluble CLEC-2 in the blood of the subject.
  6. 6. The method according to claim 5, wherein the high risk of developing cardiovascular/renal adverse events over a long period is evaluated based on a value obtained by multiplying the concentration of soluble CLEC-2 in the blood of the subject by the concentration of D-dimer.
  7. 7. The method according to any one of claims 1 to 4, wherein the high risk of developing cardiovascular/renal adverse events over a long period is evaluated based on the number of platelets in the subject in addition to the concentration of soluble CLEC-2 in the blood of the subject.
  8. 8. The method of claim 7, wherein the high risk of developing cardiovascular/renal adverse events over a long period of time is assessed based on a value obtained by dividing the concentration of soluble CLEC-2 in the blood of the subject by the number of platelets.
  9. 9. The method according to claim 7, wherein the high risk of developing cardiovascular/renal adverse events over a prolonged period is evaluated based on the concentration of D-dimer in the blood of the subject in addition to the concentration of soluble CLEC-2 and the number of platelets in the blood of the subject.
  10. 10. The method according to claim 9, wherein the long-term high risk of developing cardiovascular/renal adverse events is evaluated based on a value represented by the following formula (1): [ mathematics 1] 。
  11. 11. A method of assessing the long-term high risk of developing cardiovascular/renal adverse events and selecting an antithrombotic agent, according to the method of any one of claims 1 to 10, assessing the long-term high risk of developing cardiovascular/renal adverse events and selecting an antithrombotic agent.
  12. 12. A system for assessing high risk of developing a cardiovascular/renal adverse event over a long period of time, comprising: (1) A storage means capable of storing the concentration of soluble CLEC-2 and the concentration of D-dimer and/or the number of platelets in a blood sample from a subject; (2) A calculation means capable of calculating an index value that combines the soluble CLEC-2 concentration with a D-dimer concentration and/or a platelet number; (3) A comparison means capable of comparing the index value obtained in (2) with a threshold value, and (4) And a display means capable of displaying a result obtained by the comparison.
  13. 13. A system for evaluating a high risk of developing cardiovascular/renal adverse events over a long period of time, comprising a computer including a processor and a memory under the control of the processor, the memory having recorded thereon a program for causing the computer to execute the steps of: (1) A storage step of storing the concentration of soluble CLEC-2 and the concentration of D-dimer and/or the number of platelets in a blood sample from a subject in the memory; (2) A calculation step of calculating an index value that combines the concentration of the soluble CLEC-2 with the concentration of the D-dimer and/or the platelet count; (3) A comparison step of comparing the index value obtained in the calculation step with a threshold value, and (4) And a display step of displaying the result obtained in the comparison step.
  14. 14. An electronic medical record, a clinical examination device or an in-hospital examination system provided with the system of claim 12 or 13.
  15. 15. A kit for evaluating a high risk of developing cardiovascular/renal adverse events over a long period of time, comprising: (1) Soluble CLEC-2 assay reagent (2) The accompanying documents describe the relationship of the concentration of soluble CLEC-2, or index values consisting of a combination of the concentration of soluble CLEC-2 with the concentration of D-dimer and/or the number of platelets, to the high risk of developing cardiovascular/renal adverse events over a long period of time.

Description

Method for evaluating long-term high risk of cardiovascular and cerebrovascular/renal adverse events using soluble CLEC-2 Technical Field The present invention relates to a method for evaluating a long-term high risk of cardiovascular and cerebrovascular/renal adverse events using soluble CLEC-2 (sCLEC-2). Background The cardiovascular and cerebrovascular adverse events refer to the occurrence of cardiovascular and cerebrovascular diseases such as cerebral apoplexy, ischemic heart disease (myocardial infarction, etc.), and occlusive arteriosclerosis, etc. caused by arteriosclerosis and thrombosis, or intervention artificial dialysis, etc. Cardiovascular and cerebrovascular diseases are a very important group of diseases in japan, which are the cause of death corresponding to the number of cancers, and the first cause of death worldwide. It is important to properly evaluate the risk of onset and to perform appropriate prophylaxis/treatment. As risk factors for cardiovascular and cerebrovascular/renal adverse events, diabetes, chronic Kidney Disease (CKD), hypertension, dyslipidemia, obesity, smoking, etc. are known, and management of these factors one by one is important to reduce risk. In addition, by compounding possession of these risk factors, the risk is further increased. These risk factors are evaluated as markers, and prevention/treatment corresponding thereto is performed. For example, dyslipidemia includes risk markers such as LDL-cholesterol, and if these are abnormal, agents for ameliorating dyslipidemia such as statins are included. For diabetes, there are risk markers such as blood glucose level and hemoglobin A1C, and if these are abnormal, countermeasures such as diabetes drugs, diet, exercise, etc. are taken. Further, as for hypertension, as a prevention of cardiovascular and cerebrovascular/renal adverse events, treatments and treatments against various risks such as use of a antihypertensive agent and smoking cessation by smokers can be performed. However, even when such individual treatment/prevention is performed, patients with diabetes, hypertension, chronic kidney disease, and the like remain as a risk group for cardiovascular and cerebrovascular adverse events, and evaluation/countermeasures for the risk of cardiovascular and cerebrovascular adverse events remain important. It is known that the pathogenesis of cardiovascular and cerebrovascular adverse events such as cerebral infarction, myocardial infarction and arteriosclerosis obliterans is vascular occlusion caused by thrombus, and antithrombotic therapy has been established as a prophylactic method. In antithrombotic therapy, an antiplatelet agent is used when platelets such as arterial thrombosis are the main body of thrombus, and an anticoagulant agent is used when coagulation systems such as venous thrombosis are the main body of thrombus. In addition, in the present specification, a risk group and a high risk group for cardiovascular/renal adverse events are defined as follows. The risk group is defined as a group in which antithrombotic therapy is not generally performed, although the risk of occurrence of cardiovascular/renal adverse events is considered to be higher than that of healthy subjects. The risk group includes patients with diabetes, chronic kidney disease, hypertension, dyslipidemia, obesity, smoking habits, and the like. The high risk group is a group in which cardiovascular and cerebrovascular/renal adverse events are more likely to occur than the risk group, and antithrombotic therapy is recommended. The high risk group includes patients with past history of cerebral infarction, past history of myocardial infarction, past history of occlusive arteriosclerosis, angina pectoris, atrial fibrillation, after prosthetic valve replacement, etc. While antithrombotic therapy has an effect of inhibiting thrombosis to prevent thrombosis, it may cause hemorrhagic diseases as a side effect thereof in order to inhibit thrombosis. Therefore, for antithrombotic therapy, it is important to consider a balance between the benefits of prevention and the risk of side effects. Therefore, the use of antiplatelet drugs is not generally used for the primary prevention (prevention of patients having no past history of cardiovascular and cerebrovascular diseases) of patients suffering from risk such as diabetes, hypertension, chronic Kidney Disease (CKD), and the like, for the treatment or secondary prevention of patients having a high risk such as patients having past history of myocardial infarction, and occlusive arteriosclerosis, and the like, which are particularly prone to myocardial infarction such as angina pectoris. For the same reason, anticoagulation therapy is currently being used only as thrombosis prevention for patients with high risk such as atrial fibrillation and after prosthetic valve replacement. In this regard, it is also described in japanese type CKD diagnosis and treatment guidelines (non-patent document 1) whet