NCT04119882

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

September 28, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

October 1, 2019

Last Update Submit

September 27, 2021

Conditions

Myocardial Ischemia

Keywords

Acute Coronary SyndromeMyocardial InfarctionDiagnosisPrognosisRisk stratification

Outcome Measures

Primary Outcomes (18)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Sensitivity

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

    0 hours

  • Sensitivity

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

    1 hours

  • Sensitivity

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

    3 hours

  • Specificity

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

    0 hour

  • Specificity

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

    1 hour

  • Specificity

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

    3 hours

  • Negative Predictive Value (NPV)

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

    0 hour

  • Negative Predictive Value (NPV)

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

    1 hour

  • Negative Predictive Value (NPV)

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

    3 hour

  • Positive Predictive Value (PPV)

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

    0 hour

  • Positive Predictive Value (PPV)

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

    1 hour

  • Positive Predictive Value (PPV)

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

    3 hours

Secondary Outcomes (1)

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

    From admission to up to 6 months

Study Arms (2)

Positive for ischaemia

Blood test for 121 patients with confirmed cardiac ischemic event

Diagnostic Test: Blood collection

Negative for ischaemia

Blood test for 283 patients with no cardiac ischemic event

Diagnostic Test: Blood collection

Interventions

Blood collectionDIAGNOSTIC_TEST

New biomarker test

Negative for ischaemiaPositive for ischaemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals presenting to the Emergency Department (ED) with chest pain of suspected cardiac origin

You may qualify if:

  • 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

You may not qualify if:

  • Life expectancy less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Location

Hospital Universitario San Juan de Alicante

Sant Joan d'Alacant, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, Spain

Location

Hospital Álvaro Cunqueiro de Vigo

Vigo, Spain

Location

Chelsea and Westminister Hospital NHS Foundation Trust

London, United Kingdom

Location

East & North Hertfordshire NHS Trust, Lister Hospital

Stevenage, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Myocardial IschemiaAcute Coronary SyndromeMyocardial InfarctionDisease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Judit Cubedo

    Glycardial Diagnostics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 9, 2019

Study Start

August 20, 2019

Primary Completion

February 10, 2021

Study Completion

September 20, 2021

Last Updated

September 28, 2021

Record last verified: 2021-02

Locations

GB(2)ES(8)