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.
Study Type
OBSERVATIONAL
Enrollment
404
New biomarker test
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
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.
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Hospital Universitario Central de Asturias (HUCA)
Oviedo, Spain
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Virgen de la Macarena
Seville, Spain
Hospital Álvaro Cunqueiro de Vigo
Vigo, Spain
Chelsea and Westminister Hospital NHS Foundation Trust
London, United Kingdom
East & North Hertfordshire NHS Trust, Lister Hospital
Stevenage, United Kingdom
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