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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Coronary Syndromes
• Intervention / Treatment: Biological: blood samples

• Study Type: Interventional
• Enrollment (Anticipated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PAGANELLI FRANCK; Phone Number: 04 96 88 83; Email: franck.paganelli@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: franck PAGANELLI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: chronic coronary syndromes	Biological: blood samples; troponin measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A 2AR measure	blood sample	24 MONTHS

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: CREMIEUX François, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2021-16; 2021-A02200-41 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No