Myocardial IschemiaEDICANCT04119882
Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc
An observational study of Myocardial Ischemia, run by Glycardial Diagnostics S.L. at 10 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Blood collection
- How many people
- 404 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 20 Aug 2019to 20 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Spain8 sites
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital General Universitario Gregorio Marañón
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario Central de Asturias (HUCA)
Oviedo
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela
Hospital Universitario Virgen de la Macarena
Seville
Hospital Álvaro Cunqueiro de Vigo
Vigo
United Kingdom2 sites
Chelsea and Westminister Hospital NHS Foundation Trust
London
East & North Hertfordshire NHS Trust, Lister Hospital
Stevenage
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Ischemia
- Being tested
- Blood collection
- Keywords
- Acute Coronary Syndrome, Myocardial Infarction, Diagnosis, Prognosis, Risk stratification
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome, Myocardial Infarction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionDiagnostic test
New biomarker test
| Study group | Role | What they receive |
|---|---|---|
| Positive for ischaemia | Blood test for 121 patients with confirmed cardiac ischemic event Receives: Diagnostic Test: Blood collection | |
| Negative for ischaemia | Blood test for 283 patients with no cardiac ischemic event Receives: Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 hours
Sensitivity
Sensitivity results will be generated from subject's blood collected at different collection time points.
Measured: 0 hours
Sensitivity
Sensitivity results will be generated from subject's blood collected at different collection time points.
Measured: 1 hours
Sensitivity
Sensitivity results will be generated from subject's blood collected at different collection time points.
Measured: 3 hours
Specificity
Specificity results will be generated from subject's blood collected at different collection time points.
Measured: 0 hour
Specificity
Specificity results will be generated from subject's blood collected at different collection time points.
Measured: 1 hour
Specificity
Specificity results will be generated from subject's blood collected at different collection time points.
Measured: 3 hours
Negative Predictive Value (NPV)
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
Measured: 0 hour
Negative Predictive Value (NPV)
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
Measured: 1 hour
Negative Predictive Value (NPV)
Negative Predictive Value results will be generated from subject's blood collected at different collection time points.
Measured: 3 hour
Positive Predictive Value (PPV)
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Measured: 0 hour
Positive Predictive Value (PPV)
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Measured: 1 hour
Positive Predictive Value (PPV)
Positive Predictive Value results will be generated from subject's blood collected at different collection time points.
Measured: 3 hours
Secondary outcomes (1)
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).
Measured: From admission to up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start20 Aug 2019
- Primary completion10 Feb 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glycardial Diagnostics S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judit Cubedo, Study director, Glycardial Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119882
- Sponsor's protocol ID
- EDICA_2019
- Acronym
- EDICA
- Status last verified
- Feb 2021
- First submitted
- 1 Oct 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc as a Novel Pathologically-based Ischaemia Biomarker
- ClinicalTrials.gov ID
- NCT04119882
- Acronym / sponsor ID
- EDICA / EDICA_2019
- Conditions
- Myocardial Ischemia
- Keywords
- Acute Coronary Syndrome, Myocardial Infarction, Diagnosis, Prognosis, Risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Glycardial Diagnostics S.L.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive for ischaemia | – | Diagnostic Test: Blood collectionBlood test for 121 patients with confirmed cardiac ischemic event |
| Negative for ischaemia | – | Diagnostic Test: Blood collectionBlood test for 283 patients with no cardiac ischemic event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionNew biomarker test | Diagnostic test | Negative for ischaemia, Positive for ischaemia |
Primary outcome
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.
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.
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.
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.
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.
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.
Sensitivity
Time frame: 0 hours
Sensitivity results will be generated from subject's blood collected at different collection time points.
Sensitivity
Time frame: 1 hours
Sensitivity results will be generated from subject's blood collected at different collection time points.
Sensitivity
Time frame: 3 hours
Sensitivity results will be generated from subject's blood collected at different collection time points.
Specificity
Time frame: 0 hour
Specificity results will be generated from subject's blood collected at different collection time points.
Specificity
Time frame: 1 hour
Specificity results will be generated from subject's blood collected at different collection time points.
Specificity
Time frame: 3 hours
Specificity results will be generated from subject's blood collected at different collection time points.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Prognosis and risk-stratification. Incidence of Major following Adverse Cardiac Event (MACE).
Time frame: From admission to up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judit Cubedo study director
Glycardial Diagnostics
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia, run by Glycardial Diagnostics S.L. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cut-off value point of Apo J-Gly levels at admission for the early diagnosis of cardiac ischaemia (time frame: 0 hour). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.