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

  • STATUS
    Recruiting
  • End date
    Jun 29, 2024
  • participants needed
    312
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 29 December 2021

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.

Details
Condition Chronic Coronary Syndromes
Treatment blood samples
Clinical Study IdentifierNCT05091749
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on29 December 2021

Eligibility

Yes No Not Sure

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
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