An observational study in Myocardial Ischemia, sponsored by Glycardial Diagnostics S.L.. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Glycardial Diagnostics S.L. · Observational
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.
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 404 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →This is the only study on the registry with Glycardial Diagnostics S.L. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin
Exclusion Criteria:
Blood test for 121 patients with confirmed cardiac ischemic event
Diagnostic Test: Blood collection
Blood test for 283 patients with no cardiac ischemic event
Diagnostic Test: Blood collection
New biomarker test
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 hours
Sensitivity
Sensitivity results will be generated from subject's blood collected at different collection time points.
Time frame: 0 hours
Sensitivity
Sensitivity results will be generated from subject's blood collected at different collection time points.
Time frame: 1 hours
Sensitivity
Sensitivity results will be generated from subject's blood collected at different collection time points.
Time frame: 3 hours
Specificity
Specificity results will be generated from subject's blood collected at different collection time points.
Time frame: 0 hour
Specificity
Specificity results will be generated from subject's blood collected at different collection time points.
Time frame: 1 hour
Specificity
Specificity results will be generated from subject's blood collected at different collection time points.
Time frame: 3 hours
Negative Predictive Value (NPV)
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
Time frame: 0 hour
Negative Predictive Value (NPV)
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
Time frame: 1 hour
Negative Predictive Value (NPV)
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
Time frame: 3 hour
Positive Predictive Value (PPV)
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Time frame: 0 hour
Positive Predictive Value (PPV)
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Time frame: 1 hour
Positive Predictive Value (PPV)
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Time frame: 3 hours
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).
Time frame: From admission to up to 6 months
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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