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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

404 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-20

Study Completion Date

2021-09-20

Brief Summary

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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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Detailed Description

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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

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Myocardial Ischemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive for ischaemia

Blood test for 121 patients with confirmed cardiac ischemic event

Blood collection

Intervention Type DIAGNOSTIC_TEST

New biomarker test

Negative for ischaemia

Blood test for 283 patients with no cardiac ischemic event

Blood collection

Intervention Type DIAGNOSTIC_TEST

New biomarker test

Interventions

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Blood collection

New biomarker test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No