Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc
- Conditions
- Myocardial Ischemia
- Interventions
- Diagnostic Test: Blood collection
- Registration Number
- NCT04119882
- Lead Sponsor
- Glycardial Diagnostics S.L.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Negative for ischaemia Blood collection Blood test for 283 patients with no cardiac ischemic event Positive for ischaemia Blood collection Blood test for 121 patients with confirmed cardiac ischemic event
- Primary Outcome Measures
Name Time Method Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia 3 hours 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.
Specificity 3 hours Specificity results will be generated from subject's blood collected at different collection time points.
Area under the Receiver Operating characteristic Curve (A-ROC curve) 3 hours 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.
Sensitivity 3 hours Sensitivity results will be generated from subject's blood collected at different collection time points.
Positive Predictive Value (PPV) 3 hours Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Negative Predictive Value (NPV) 3 hour Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
- Secondary Outcome Measures
Name Time Method Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE). From admission to up to 6 months Subjects will be assessed for the in-hospital and 6-month incidence of any Major following Adverse Cardiac Event (MACE).
Trial Locations
- Locations (10)
Hospital Universitario Central de Asturias (HUCA)
🇪🇸Oviedo, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario San Juan de Alicante
🇪🇸San Juan De Alicante, Spain
Hospital Clínico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Spain
Hospital Álvaro Cunqueiro de Vigo
🇪🇸Vigo, Spain
Hospital Universitario Virgen de la Macarena
🇪🇸Sevilla, Spain
Chelsea and Westminister Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
East & North Hertfordshire NHS Trust, Lister Hospital
🇬🇧Stevenage, United Kingdom