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

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ClinicalTrials.gov Identifier: NCT04119882
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Glycardial Diagnostics S.L.

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.

Condition or disease Intervention/treatment
Myocardial Ischemia 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) as well as at follow-up (3, 6, 9 and 12 months). 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 prognostic value.

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Study Type : Observational
Estimated Enrollment : 646 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Positive for ischaemia
Blood test for 363 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




Primary Outcome Measures :
  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. Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia [ Time Frame: 24 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.

  5. Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia [ Time Frame: 72 hours post-admission or at discharge an average of 72 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.

  6. 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.

  7. 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.

  8. 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.

  9. Area under the Receiver Operating characteristic Curve (A-ROC curve) [ Time Frame: 24 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.

  10. Area under the Receiver Operating characteristic Curve (A-ROC curve) [ Time Frame: 72 hours post-admission or at discharge an average of 72 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.

  11. Sensitivity [ Time Frame: 0 hours ]
    Sensitivity results will be generated from subject's blood collected at different collection time points.

  12. Sensitivity [ Time Frame: 1 hours ]
    Sensitivity results will be generated from subject's blood collected at different collection time points.

  13. Sensitivity [ Time Frame: 3 hours ]
    Sensitivity results will be generated from subject's blood collected at different collection time points.

  14. Sensitivity [ Time Frame: 24 hours ]
    Sensitivity results will be generated from subject's blood collected at different collection time points.

  15. Sensitivity [ Time Frame: 72 hours post-admission or at discharge an average of 72 hours ]
    Sensitivity results will be generated from subject's blood collected at different collection time points.

  16. Specificity [ Time Frame: 0 hour ]
    Specificity results will be generated from subject's blood collected at different collection time points.

  17. Specificity [ Time Frame: 1 hour ]
    Specificity results will be generated from subject's blood collected at different collection time points.

  18. Specificity [ Time Frame: 3 hours ]
    Specificity results will be generated from subject's blood collected at different collection time points.

  19. Specificity [ Time Frame: 24 hours ]
    Specificity results will be generated from subject's blood collected at different collection time points.

  20. Specificity [ Time Frame: 72 hours post-admission or at discharge an average of 72 hours ]
    Specificity results will be generated from subject's blood collected at different collection time points.

  21. 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.

  22. 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.

  23. 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.

  24. Negative Predictive Value (NPV) [ Time Frame: 24 hour ]
    Negative Predictive Value results will be generated from subject's blood collected at different collection time points.

  25. Negative Predictive Value (NPV) [ Time Frame: 72 hours post-admission or at discharge an average of 72 hours ]
    Negative Predictive Value results will be generated from subject's blood collected at different collection time points.

  26. 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.

  27. 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.

  28. 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.

  29. Positive Predictive Value (PPV) [ Time Frame: 24 hours ]
    Positive Predictive Value results will be generated from subject's blood collected at different collection time points.

  30. Positive Predictive Value (PPV) [ Time Frame: 72 hours post-admission or at discharge an average of 72 hours ]
    Positive Predictive Value results will be generated from subject's blood collected at different collection time points.


Secondary Outcome Measures :
  1. Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE). [ Time Frame: From admission to up to 12 months ]
    Subjects will be assessed for the in-hospital and 12-month incidence of any Major following Adverse Cardiac Event (MACE).


Biospecimen Retention:   Samples Without DNA
Blood serum Blood plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin
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 12 months
  • Previous inclusion in a therapy-related clinical trial (except clinical trials testing Medical Devices such as stents and/or balloons)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119882


Contacts
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Contact: Nuria C Lluch 34934020259 ext 20259 nlluch@glycardial.com
Contact: Judit Cubedo 34934020259 ext 20259 jcubedo@glycardial.com

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain
Hospital Universitario San Juan de Alicante Recruiting
San Juan De Alicante, Spain
Sponsors and Collaborators
Glycardial Diagnostics S.L.
Investigators
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Study Director: Judit Cubedo Glycardial Diagnostics

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Responsible Party: Glycardial Diagnostics S.L.
ClinicalTrials.gov Identifier: NCT04119882     History of Changes
Other Study ID Numbers: EDICA_2019
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glycardial Diagnostics S.L.:
Acute Coronary Syndrome
Myocardial Infarction
Diagnosis
Prognosis
Risk stratification
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases