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Completed

NCT Number: NCT04119882

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

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.

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Key information

Conditions

Myocardial Ischemia Acute Coronary Syndrome Cardiovascular Diseases Disease Heart Diseases Infarction Ischemia Myocardial Infarction Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood collection

Diagnostic Test

New biomarker test

Primary outcomes

  1. Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia

    Time frame: 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.

  2. Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia

    Time frame: 1 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.

  3. Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia

    Time frame: 3 hours

    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.

  4. Area under the Receiver Operating characteristic Curve (A-ROC curve)

    Time frame: 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.

  5. Area under the Receiver Operating characteristic Curve (A-ROC curve)

    Time frame: 1 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.

  6. Area under the Receiver Operating characteristic Curve (A-ROC curve)

    Time frame: 3 hours

    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.

  7. Sensitivity

    Time frame: 0 hours

    Sensitivity results will be generated from subject's blood collected at different collection time points.

  8. Sensitivity

    Time frame: 1 hours

    Sensitivity results will be generated from subject's blood collected at different collection time points.

  9. Sensitivity

    Time frame: 3 hours

    Sensitivity results will be generated from subject's blood collected at different collection time points.

  10. Specificity

    Time frame: 0 hour

    Specificity results will be generated from subject's blood collected at different collection time points.

  11. Specificity

    Time frame: 1 hour

    Specificity results will be generated from subject's blood collected at different collection time points.

  12. Specificity

    Time frame: 3 hours

    Specificity results will be generated from subject's blood collected at different collection time points.

  13. Negative Predictive Value (NPV)

    Time frame: 0 hour

    Negative Predictive Value results will be generated from subject's blood collected at different collection time points.

  14. Negative Predictive Value (NPV)

    Time frame: 1 hour

    Negative Predictive Value results will be generated from subject's blood collected at different collection time points.

  15. Negative Predictive Value (NPV)

    Time frame: 3 hour

    Negative Predictive Value results will be generated from subject's blood collected at different collection time points.

  16. Positive Predictive Value (PPV)

    Time frame: 0 hour

    Positive Predictive Value results will be generated from subject's blood collected at different collection time points.

  17. Positive Predictive Value (PPV)

    Time frame: 1 hour

    Positive Predictive Value results will be generated from subject's blood collected at different collection time points.

  18. Positive Predictive Value (PPV)

    Time frame: 3 hours

    Positive Predictive Value results will be generated from subject's blood collected at different collection time points.

Secondary outcomes

  1. Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE).

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Glycardial Diagnostics S.L.

Industry

Registry information

Official study title

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

Acronym: EDICA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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