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NCT Number: NCT05091749

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

blood samples

Biological

troponin measurement

Primary outcomes

  1. A 2AR measure

    Time frame: 24 MONTHS

    blood sample

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: ADOCAD

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 25, 2021
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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