Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc

Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04119882

Acronym

EDICA

Enrollment

404

Registered

2019-10-09

Start date

2019-08-20

Completion date

2021-09-20

Last updated

2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia

Keywords

Acute Coronary Syndrome, Myocardial Infarction, Diagnosis, Prognosis, Risk stratification

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.

Interventions

DIAGNOSTIC_TESTBlood collection

New biomarker test

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity	0 hours	Sensitivity results will be generated from subject's blood collected at different collection time points.
Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia	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.
Area under the Receiver Operating characteristic Curve (A-ROC curve)	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.
Positive Predictive Value (PPV)	0 hour	Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Specificity	0 hour	Specificity results will be generated from subject's blood collected at different collection time points.
Negative Predictive Value (NPV)	0 hour	Negative Predictive Value results will be generated from subject's blood collected at different collection time points.

Secondary

Measure	Time frame	Description
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).

Countries

Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026