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

Myocardial Ischemia Clinical Trial

— EDICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119882
• Other study ID #: EDICA_2019
• Status: Completed
• Start date: August 20, 2019
• Est. completion date: September 20, 2021

Study information

• Verified date: February 2021
• Source: Glycardial Diagnostics S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: September 20, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Blood collection
New biomarker test

Locations

Country	Name	City	State
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
United Kingdom	Chelsea and Westminister Hospital NHS Foundation Trust	London
United Kingdom	East & North Hertfordshire NHS Trust, Lister Hospital	Stevenage

Sponsors (1)

Lead Sponsor	Collaborator
Glycardial Diagnostics S.L.

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Sensitivity	Sensitivity results will be generated from subject's blood collected at different collection time points.	0 hours
Primary	Sensitivity	Sensitivity results will be generated from subject's blood collected at different collection time points.	1 hours
Primary	Sensitivity	Sensitivity results will be generated from subject's blood collected at different collection time points.	3 hours
Primary	Specificity	Specificity results will be generated from subject's blood collected at different collection time points.	0 hour
Primary	Specificity	Specificity results will be generated from subject's blood collected at different collection time points.	1 hour
Primary	Specificity	Specificity results will be generated from subject's blood collected at different collection time points.	3 hours
Primary	Negative Predictive Value (NPV)	Negative Predictive Value results will be generated from subject's blood collected at different collection time points.	0 hour
Primary	Negative Predictive Value (NPV)	Negative Predictive Value results will be generated from subject's blood collected at different collection time points.	1 hour
Primary	Negative Predictive Value (NPV)	Negative Predictive Value results will be generated from subject's blood collected at different collection time points.	3 hour
Primary	Positive Predictive Value (PPV)	Positive Predictive Value results will be generated from subject's blood collected at different collection time points.	0 hour
Primary	Positive Predictive Value (PPV)	Positive Predictive Value results will be generated from subject's blood collected at different collection time points.	1 hour
Primary	Positive Predictive Value (PPV)	Positive Predictive Value results will be generated from subject's blood collected at different collection time points.	3 hours
Secondary	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