Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays

Assistance Publique Hopitaux De Marseille1 site in 1 country312 target enrollmentNovember 9, 2021

ConditionsChronic Coronary Syndromes

Interventionsblood samples

Drugsblood samples

Overview

Phase: Not Applicable
Intervention: blood samples
Conditions: Chronic Coronary Syndromes
Sponsor: Assistance Publique Hopitaux De Marseille
Enrollment: 312
Locations: 1
Primary Endpoint: A 2AR measure
Status: Active, not recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Transversal, national, multi-center study with progressive recruitment designed to assess the diagnostic accuracy of A2AR expression for the identification of significant obstructive CAD (FFR<0.8) of patients suspected of CCS compared to the gold standard.

To assess the diagnostic accuracy of the A2AR profile (i.e. KD/EC50) for identifying myocardial ischemia in patients with suspected CCS compared to the gold standard inducible myocardial ischemia.
To determine the best threshold value for A2AR expression for identifying significant obstructive CAD (FFR<0,8) in patients with CCS, and to estimate the diagnostic performances associated with the identified threshold
To determine the best threshold value for A2AR profile (i.e. KD/EC50) for identifying myocardial ischemia (See annex 2) in patients with CCS and to estimate the diagnostic performances associated with the identified threshold.

Registry

clinicaltrials.gov

Start Date

November 9, 2021

End Date

December 1, 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Assistance Publique Hopitaux De Marseille

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Man or woman aged ≥18 and \<90 years old;
•Must not be of child-bearing potential (≥1 year post-menopausal, contraceptive, or surgically sterile);
•Symptoms suggestive of CCS and intermediate PTP (15-85%) according to the Diamond classification (2);
•Undergone at least one stress imaging test (annex 3) or an abnormal coronary Computed Tomography Angiography (CTA) with the recommendation to perform ICA with FFR in all intermediate lesions;
•Non-contributive ECG (resting 18-lead);
•Normal echocardiography with left ventricular ejection fraction (LVEF) \>50%;
•Cardiac troponin level \<99th percentile;
•Intended for an invasive strategy for CCS;
•Affiliated to or beneficiary of, a social security system;
•Signed written informed consent.

Exclusion Criteria

•Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
•Pregnant, parturient or breastfeeding woman
•Person deprived of liberty for judicial or administrative decision
•Person under psychiatric care
•Minor person (non-emancipated)
•History of CAD or known CAD
•Suspected acute coronary syndrome (ACS: annex 4)
•Inability to undergo adenosine testing
•Allergy to iodinated contrast media
•Bleeding diathesis