Chronic Coronary SyndromesADOCADNCT05091749
Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
A study testing blood samples in people with Chronic Coronary Syndromes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndromes
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Chronic Coronary Syndromes
- Being tested
- blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
troponin measurement
| Study group | Role | What they receive |
|---|---|---|
| chronic coronary syndromes | Experimental | Not described Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 2AR measure
blood sample
Measured: 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start9 Nov 2021
- Primary completion10 Mar 2024
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CREMIEUX François, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091749
- Sponsor's protocol ID
- 2021-16
- Other IDs
- 2021-A02200-41
- Acronym
- ADOCAD
- Status last verified
- May 2025
- First submitted
- 13 Oct 2021
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Significant Coronary Artery Disease by Promising Biomarker: A2A Adenosine Receptor (A2AR) Assays
- ClinicalTrials.gov ID
- NCT05091749
- Acronym / sponsor ID
- ADOCAD / 2021-16
- Conditions
- Chronic Coronary Syndromes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic coronary syndromes | Experimental | Biological: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (23 listed)
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty for judicial or administrative decision
- Person under psychiatric care
- Minor person (non-emancipated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplestroponin measurement | Biological | chronic coronary syndromes |
Primary outcome
A 2AR measure
Time frame: 24 MONTHS
blood sample
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CREMIEUX François study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Chronic Coronary Syndromes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 2AR measure (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.