Trial record 1 of 1 for:
NCT04119882
Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc (EDICA)
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| ClinicalTrials.gov Identifier: NCT04119882 |
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Recruitment Status :
Completed
First Posted : October 9, 2019
Last Update Posted : September 28, 2021
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Sponsor:
Glycardial Diagnostics S.L.
Information provided by (Responsible Party):
Glycardial Diagnostics S.L.
- Study Details
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Myocardial Ischemia | Diagnostic Test: Blood collection |
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 |
| Actual Enrollment : | 404 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker |
| Actual Study Start Date : | August 20, 2019 |
| Actual Primary Completion Date : | February 10, 2021 |
| Actual Study Completion Date : | September 20, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Coronary Artery Disease
| Group/Cohort | Intervention/treatment |
|---|---|
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Positive for ischaemia
Blood test for 121 patients with confirmed cardiac ischemic event
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Diagnostic Test: Blood collection
New biomarker test |
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Negative for ischaemia
Blood test for 283 patients with no cardiac ischemic event
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Diagnostic Test: Blood collection
New biomarker test |
Primary Outcome Measures :
- Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia [ Time Frame: 0 hour ]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.
- Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia [ Time Frame: 1 hour ]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.
- Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia [ Time Frame: 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.
- Area under the Receiver Operating characteristic Curve (A-ROC curve) [ Time Frame: 0 hour ]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.
- Area under the Receiver Operating characteristic Curve (A-ROC curve) [ Time Frame: 1 hour ]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.
- Area under the Receiver Operating characteristic Curve (A-ROC curve) [ Time Frame: 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 [ Time Frame: 0 hours ]Sensitivity results will be generated from subject's blood collected at different collection time points.
- Sensitivity [ Time Frame: 1 hours ]Sensitivity results will be generated from subject's blood collected at different collection time points.
- Sensitivity [ Time Frame: 3 hours ]Sensitivity results will be generated from subject's blood collected at different collection time points.
- Specificity [ Time Frame: 0 hour ]Specificity results will be generated from subject's blood collected at different collection time points.
- Specificity [ Time Frame: 1 hour ]Specificity results will be generated from subject's blood collected at different collection time points.
- Specificity [ Time Frame: 3 hours ]Specificity results will be generated from subject's blood collected at different collection time points.
- Negative Predictive Value (NPV) [ Time Frame: 0 hour ]Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
- Negative Predictive Value (NPV) [ Time Frame: 1 hour ]Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
- Negative Predictive Value (NPV) [ Time Frame: 3 hour ]Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
- Positive Predictive Value (PPV) [ Time Frame: 0 hour ]Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
- Positive Predictive Value (PPV) [ Time Frame: 1 hour ]Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
- Positive Predictive Value (PPV) [ Time Frame: 3 hours ]Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Secondary Outcome Measures :
- Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE). [ Time Frame: 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).
Biospecimen Retention: Samples Without DNA
Blood serum
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin
Criteria
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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119882
Locations
| 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 Central de Asturias (HUCA) | |
| Oviedo, Spain | |
| Hospital Universitario San Juan de Alicante | |
| San Juan De Alicante, Spain | |
| Hospital Clínico Universitario de Santiago de Compostela | |
| Santiago De Compostela, Spain | |
| Hospital Universitario Virgen de la Macarena | |
| Sevilla, Spain | |
| Hospital Álvaro Cunqueiro de Vigo | |
| Vigo, Spain | |
| United Kingdom | |
| Chelsea and Westminister Hospital NHS Foundation Trust | |
| London, United Kingdom | |
| East & North Hertfordshire NHS Trust, Lister Hospital | |
| Stevenage, United Kingdom | |
Sponsors and Collaborators
Glycardial Diagnostics S.L.
Investigators
| Study Director: | Judit Cubedo | Glycardial Diagnostics |
| Responsible Party: | Glycardial Diagnostics S.L. |
| ClinicalTrials.gov Identifier: | NCT04119882 |
| Other Study ID Numbers: |
EDICA_2019 |
| First Posted: | October 9, 2019 Key Record Dates |
| Last Update Posted: | September 28, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Glycardial Diagnostics S.L.:
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Acute Coronary Syndrome Myocardial Infarction Diagnosis Prognosis Risk stratification |
Additional relevant MeSH terms:
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Acute Coronary Syndrome Myocardial Ischemia Coronary Artery Disease Ischemia Pathologic Processes Heart Diseases |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |