Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc

Study Overview
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Brief Summary
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The objective of the study is to assess the performance characteristics of Apo J-Glyc as a novel biomarker for the early detection of myocardial ischaemia in patients with suspected acute coronary syndromes.

Detailed Description
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This in vitro diagnosis clinical validation will test the Performance Characteristics of Apo J-Glyc measured with a novel in vitro diagnostic (IVD) test. Blood samples from eligible consenting subjects will be collected at hospital admission, throughout different post admission times (1h, 3h, 24h and 72h or discharge). The quantification of circulating Apo J-Glyc levels will be analysed in correlation with clinical data providing information about Apo J-Glyc as an ischaemia biomarker and its diagnostic and 6-months prognostic value.

Official Title
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Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Diagnostic Test: Blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal or above 18 years old Chest pain of suspected cardiac origin Signature of informed consent Able and willing to comply with study requirements Exclusion Criteria: Prior inclusion in the same study Life expectancy less than 6 months Previous inclusion in a therapy-related clinical trial (except clinical trials testing Medical Devices such as stents and/or balloons)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive for ischaemia<br>Blood test for 121 patients with confirmed cardiac ischemic event | Diagnostic Test: Blood collection<br>* New biomarker test<br>|
| Negative for ischaemia<br>Blood test for 283 patients with no cardiac ischemic event | Diagnostic Test: Blood collection<br>* New biomarker test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia | Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia as compared to final diagnosis at discharge following routine practice to manage chest pain patients with possible ACS. | 0 hour | 
| Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia | Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia as compared to final diagnosis at discharge following routine practice to manage chest pain patients with possible ACS. | 1 hour | 
| Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia | Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia as compared to final diagnosis at discharge following routine practice to manage chest pain patients with possible ACS. | 3 hours | 
| Area under the Receiver Operating characteristic Curve (A-ROC curve) | Area under the Receiver Operating characteristic Curve will be used to determine the optimum clinical sensitivity and specificity. Results will be generated from subject's blood collected at different collection time points. | 0 hour | 
| Area under the Receiver Operating characteristic Curve (A-ROC curve) | Area under the Receiver Operating characteristic Curve will be used to determine the optimum clinical sensitivity and specificity. Results will be generated from subject's blood collected at different collection time points. | 1 hour | 
| Area under the Receiver Operating characteristic Curve (A-ROC curve) | Area under the Receiver Operating characteristic Curve will be used to determine the optimum clinical sensitivity and specificity. Results will be generated from subject's blood collected at different collection time points. | 3 hours | 
| Sensitivity | Sensitivity results will be generated from subject's blood collected at different collection time points. | 0 hours | 
| Sensitivity | Sensitivity results will be generated from subject's blood collected at different collection time points. | 1 hours | 
| Sensitivity | Sensitivity results will be generated from subject's blood collected at different collection time points. | 3 hours | 
| Specificity | Specificity results will be generated from subject's blood collected at different collection time points. | 0 hour | 
| Specificity | Specificity results will be generated from subject's blood collected at different collection time points. | 1 hour | 
| Specificity | Specificity results will be generated from subject's blood collected at different collection time points. | 3 hours | 
| Negative Predictive Value (NPV) | Negative Predictive Value results will be generated from subject's blood collected at different collection time points. | 0 hour | 
| Negative Predictive Value (NPV) | Negative Predictive Value results will be generated from subject's blood collected at different collection time points. | 1 hour | 
| Negative Predictive Value (NPV) | Negative Predictive Value results will be generated from subject's blood collected at different collection time points. | 3 hour | 
| Positive Predictive Value (PPV) | Positive Predictive Value results will be generated from subject's blood collected at different collection time points. | 0 hour | 
| Positive Predictive Value (PPV) | Positive Predictive Value results will be generated from subject's blood collected at different collection time points. | 1 hour | 
| Positive Predictive Value (PPV) | Positive Predictive Value results will be generated from subject's blood collected at different collection time points. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE). | Subjects will be assessed for the in-hospital and 6-month incidence of any Major following Adverse Cardiac Event (MACE). | From admission to up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Myocardial Infarction, Diagnosis, Prognosis, Risk stratification