NCT05091749Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2025

Brief summary (registry, in English)

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. 1. 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. 2. 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 3. 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.

Status (registry): Active, not recruiting
Study type: Interventional
Enrollment: 312 (estimated)
First submitted: 13 Oct 2021
Start date: 9 Nov 2021
Primary completion date: 10 Mar 2024
Lead sponsor: Assistance Publique Hopitaux De Marseille
Diseases: Coronary artery disease
NCT number: NCT05091749

What you commit to

Study type: Interventional
Planned participants: 312
From 9 Nov 2021 to the primary completion date, 10 Mar 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Person under psychiatric care

Lab values

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
- Known significant bleeding risk according to physician judgment
- Severe hepatic failure (ASAT, ALAT\>3ULN)
- Ischemic stroke within 1 month or a history of hemorrhagic stroke
- Bradycardia
- Platelet count \<100 G/L
- Hemoglobin \<10g/dl
- Major surgery or trauma within 10 days
- Life expectancy \<1 year
- Pre-test Probability \<15% or \>85%
- History and clinical examination suggesting non-cardiac chest pain
- Contraindication to coronary angiography
- Thyroid disorder
- Refusal to participate

Other

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

Who the study is looking for

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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status	Marseille	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.