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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Active, not recruiting

Conditions: Chronic Coronary Syndromes

Treatments: Biological: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT05091749

2021-16

2021-A02200-41 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 312 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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312 participants in 1 patient group

chronic coronary syndromes

Experimental group

Treatment:

Biological: blood samples