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

NCT ID: NCT05091749

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2025-12-01

Brief 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.

Conditions

Chronic Coronary Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

chronic coronary syndromes

Group Type: EXPERIMENTAL

blood samples

Intervention Type: BIOLOGICAL

troponin measurement

Interventions

blood samples

troponin measurement

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

CREMIEUX François

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2021-A02200-41

Identifier Type: OTHER

Identifier Source: secondary_id

2021-16

Identifier Type: -

Identifier Source: org_study_id