Clinical trial NCT05091749: Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
Official title: Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Coronary Syndromes
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: A 2AR measure
timeFrame: 24 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: CREMIEUX François
role: STUDY_DIRECTOR
References: