A2 AR as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.

One proposed strategy is the stratification of troponin-negative patients with biomarker testing at presentation to facilitate the clinically-appropriate rapid discharge from the emergency department of patients who present with low-intermediate risk chest pain, and conversely to triage appropriate Non sustained ST elevation acute coronary syndrome (NSTE-ACS) patients to Cardiology beds, stress and non-invasive imaging modalities. Biomarkers such as high-sensitivity troponin (hs-cTn), heart-type fatty acid-binding protein (H-FABP), CRP, brain natriuretic peptide (BNP); and copeptin and ischemia-modified albumin are an important advance for diagnostic testing for ACS (4). Regarding novel biomarker testing at presentation, the addition of these biomarkers demonstrated increased sensitivity at an acceptable QALY threshold, but more evidence is needed (5,6). A reliable method for the diagnosis of minimal cardiac ischemia would meet a strong demand for the sensitive diagnosis of coronary artery disease in patients with chest pain but unremarkable ECGs and biomarkers. Adenosine is an endogenous nucleoside cardioprotective agent. Its cardiovascular effects are mediated throught the activation of A2A Receptor (A2 AR) and play a major role in the regulation of Coronary flow CF. As altered coronary blood flow occurs in patients with CAD, it has been showed that that A2AR expression and functional activity play a role in CAD. In a previous studies the team have developped an agonist-like monoclonal antibody to study expression level of this receptor and their functional activity. Recently , Gariboldi demonstrated that measuring the expression level of A2AR on peripheral blood mononuclear cells ( PBMC) represents a good tool to address in situ expression in coronary tissues of CAD patients.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

About this study

In the diagnostic setting of ACS, expression and functionnaly activity of A2AR could be a sensitive detection method for ischemia. It would be a powerful tool for risk stratification of patients presenting with chest pain but unremarkable ECG and blood tests. the investigateors therefore designed a blind multicentrique prospective study to evaluate expression and functionnaly activity of A2AR in the management of undifferentiated chest pain The objective of the study was to evaluate diagnostic accuracy between this novel biomarkers A2AR and invasive and non -invasive evaluation of patients with suspected coronary artery disease (CAD).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

A subject with a symptomatology consistent with acute coronary syndrome for at least 15 min and less than 6 hours (eg discomfort, tightness or chest pain, pain radiating to the left arm or both arms, pain in the jaw, Pain in the back / neck / stomach, dyspnea, cold sweats, nausea / vomiting, dizziness)
Man or woman,
over 18 years,
Patient agreeing to participate in the study and having signed informed consent.

Exclusion criteria

Minor Patient
Patient not having signed informed consent (refusal, physical or mental incapacity ...) --Patient with an evolutive septic process, neoplasia undergoing treatment, dialysed renal insufficiency, history of surgery or coronary angioplasty less than six months old.

Cardiac, renal or hepatic transplantation

elevation of troponin
Cardiac arrest
A subject whose symptomatology clearly eliminates acute coronary syndrome (penetrating trauma, traumatic lesion by crushing ...)
Patient who died between the time of inclusion and arrival in cardiology intensive care (ICU)
Patient withdrawing consent during study
Vulnerable people unable to fully integrate the objectives, benefits and risks of research and to give their informed consent
Pregnant women
Persons deprived of their liberty
Persons admitted to health and social facilities for therapeutic purposes
Protected persons

Treatment and study plan

blood samples

Biological

to evaluate expression and functionnaly activity of A2AR

Primary outcomes

dosage of adenosine

Time frame: 12 MONTHS

evaluate expression and functionnaly activity of A2AR

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

A 2A Receptor (A2 AR) as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Jul 14, 2017
Registry last updated: Oct 12, 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.

Published trials that share one or more normalized conditions with this study.

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