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

GlyCardial Diagnostics

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Diagnostic Test: Blood collection

Study type: Observational

Funder types: Industry

Identifiers

NCT04119882

EDICA_2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 404 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

404 participants in 2 patient groups

Positive for ischaemia

Description:

Blood test for 121 patients with confirmed cardiac ischemic event

Treatment:

Diagnostic Test: Blood collection

Negative for ischaemia

Description:

Blood test for 283 patients with no cardiac ischemic event

Treatment:

Diagnostic Test: Blood collection