A2 AR as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.
Primary Purpose
Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Coronary Syndrome
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acute coronary syndrome
Arm Description
Outcomes
Primary Outcome Measures
dosage of adenosine
evaluate expression and functionnaly activity of A2AR
Secondary Outcome Measures
Full Information
NCT ID
NCT03218007
First Posted
June 30, 2017
Last Updated
October 11, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03218007
Brief Title
A2 AR as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
May 15, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acute coronary syndrome
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
to evaluate expression and functionnaly activity of A2AR
Primary Outcome Measure Information:
Title
dosage of adenosine
Description
evaluate expression and functionnaly activity of A2AR
Time Frame
12 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29654194
Citation
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.
Results Reference
derived
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A2 AR as a Novel Biomarkers for Physician Decision-making Improvement Evaluation's Patients With Suspected Acute Coronary Syndrome But Negative Troponin.
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