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

NCT05091749 | Active Not Recruiting

• 2 other identifiers: 2021-162021-A02200-41
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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. 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. 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. 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

Outcome Measures

Primary Outcomes (1)

• A 2AR measure

  blood sample

  24 MONTHS

Study Arms (1)

chronic coronary syndromes

EXPERIMENTAL

Biological: blood samples

Interventions

blood samples BIOLOGICAL

troponin measurement

chronic coronary syndromes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• CREMIEUX François

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: November 9, 2021
• Primary Completion: March 10, 2024
• Study Completion: December 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

FR (1)