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

Primary Purpose

Chronic Coronary Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Coronary Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chronic coronary syndromes

Arm Description

Outcomes

Primary Outcome Measures

A 2AR measure
blood sample

Secondary Outcome Measures

Full Information

First Posted
October 13, 2021
Last Updated
December 20, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05091749
Brief Title
Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
Acronym
ADOCAD
Official Title
Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Syndromes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chronic coronary syndromes
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood samples
Intervention Description
troponin measurement
Primary Outcome Measure Information:
Title
A 2AR measure
Description
blood sample
Time Frame
24 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PAGANELLI FRANCK
Phone
04 96 88 83
Email
franck.paganelli@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CREMIEUX François
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
franck PAGANELLI

12. IPD Sharing Statement

Learn more about this trial

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

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