Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive for ischaemia | Blood test for 121 patients with confirmed cardiac ischemic event |
| |
| Negative for ischaemia | Blood test for 283 patients with no cardiac ischemic event |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood collection | Diagnostic Test | New biomarker test |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judit Cubedo | Glycardial Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||||
| Hospital General Universitario Gregorio Marañón |
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D004194 | Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood serum
| 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 |
| Madrid |
| Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| 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 |
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |