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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Diagnostic test: Blood collection

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.

• Study Type: Observational
• Enrollment (Actual): 404

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias (HUCA)
  • San Juan De Alicante, Spain
    • Hospital Universitario San Juan de Alicante
  • Santiago De Compostela, Spain
    • Hospital Clinico Universitario de Santiago de Compostela
  • Sevilla, Spain
    • Hospital Universitario Virgen De La Macarena
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro de Vigo
• United Kingdom
  • London, United Kingdom
    • Chelsea and Westminister Hospital NHS Foundation Trust
  • Stevenage, United Kingdom
    • East & North Hertfordshire NHS Trust, Lister Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive for ischaemia; Blood test for 121 patients with confirmed cardiac ischemic event	Diagnostic test: Blood collection; New biomarker test
Negative for ischaemia; Blood test for 283 patients with no cardiac ischemic event	Diagnostic test: Blood collection; New biomarker test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Glycardial Diagnostics S.L.
• Investigators: Study Director: Judit Cubedo, Glycardial Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Prognosis; Diagnosis; Risk stratification; Acute Coronary Syndrome; Myocardial Infarction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: EDICA_2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No