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

NCT03218007 | Completed

• 2 other identifiers: 2017-362017-A01836-47
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• dosage of adenosine

  evaluate expression and functionnaly activity of A2AR

  12 MONTHS

Study Arms (1)

acute coronary syndrome

EXPERIMENTAL

Biological: blood samples

Interventions

blood samples BIOLOGICAL

to evaluate expression and functionnaly activity of A2AR

acute coronary syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• Paganelli F, Resseguier N, Marlinge M, Laine M, Malergue F, Kipson N, Armangau P, Pezzoli N, Kerbaul F, Bonello L, Mottola G, Fenouillet E, Guieu R, Ruf J. Specific Pharmacological Profile of A2A Adenosine Receptor Predicts Reduced Fractional Flow Reserve in Patients With Suspected Coronary Artery Disease. J Am Heart Assoc. 2018 Apr 13;7(8):e008290. doi: 10.1161/JAHA.117.008290.

  PMID: 29654194 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Olivier ARNAUD

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 14, 2017
• Study Start: November 10, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: October 12, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)