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Active, not recruitingNCT05091749ADOCADUpdated Jun 3, 2025

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

An interventional study of blood samples in Chronic Coronary Syndromes, sponsored by Assistance Publique Hopitaux De Marseille. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
312
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

  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.
02

Conditions studied

03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 312 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
    • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
312 participants (estimated)

Study arms

  • Experimental
    chronic coronary syndromes

    Biological: blood samples

Interventions

  • Biologicalblood samples

    troponin measurement

06

What researchers measure

Primary outcomes

  1. A 2AR measure

    blood sample

    Time frame: 24 MONTHS

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05091749
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Oct 25, 2021
Start date
Nov 9, 2021
Primary completion
Mar 10, 2024
Completion
Dec 1, 2025 (estimated)
Last update
Jun 3, 2025

Study contacts

CREMIEUX François
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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