Clinical trial NCT04119882: Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc
Official title: Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Keywords: Acute Coronary Syndrome
Myocardial Infarction
Diagnosis
Prognosis
Risk stratification
Lead sponsor: Glycardial Diagnostics S.L.
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin

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.

Eligibility 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)

Primary outcomes:
measure: Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia
timeFrame: 0 hour
measure: Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia
timeFrame: 1 hour
measure: Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia
timeFrame: 3 hours
measure: Area under the Receiver Operating characteristic Curve (A-ROC curve)
timeFrame: 0 hour
measure: Area under the Receiver Operating characteristic Curve (A-ROC curve)
timeFrame: 1 hour
measure: Area under the Receiver Operating characteristic Curve (A-ROC curve)
timeFrame: 3 hours
measure: Sensitivity
timeFrame: 0 hours
measure: Sensitivity
timeFrame: 1 hours
measure: Sensitivity
timeFrame: 3 hours
measure: Specificity
timeFrame: 0 hour
measure: Specificity
timeFrame: 1 hour
measure: Specificity
timeFrame: 3 hours
measure: Negative Predictive Value (NPV)
timeFrame: 0 hour
measure: Negative Predictive Value (NPV)
timeFrame: 1 hour
measure: Negative Predictive Value (NPV)
timeFrame: 3 hour
measure: Positive Predictive Value (PPV)
timeFrame: 0 hour
measure: Positive Predictive Value (PPV)
timeFrame: 1 hour
measure: Positive Predictive Value (PPV)
timeFrame: 3 hours
Secondary outcomes:
measure: Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE).
timeFrame: From admission to up to 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
city: San Juan De Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Santiago De Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro de Vigo
city: London
country: United Kingdom
facility: Chelsea and Westminister Hospital NHS Foundation Trust
city: Stevenage
country: United Kingdom
facility: East & North Hertfordshire NHS Trust, Lister Hospital
Study officials:
affiliation: Glycardial Diagnostics
name: Judit Cubedo
role: STUDY_DIRECTOR
References: