Chronic Coronary Artery DiseaseRIMACINCT04640844
Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia
A study testing blood sample in people with Chronic Coronary Artery Disease, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The chronic coronary artery disease could be detected by a drop in the expression of A2A receptors to adenosine, while high values of the KD / EC50 ratio are a sign of coronary ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Artery Disease
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients admitted for preoperative assessment of vascular surgery of the aorta and / or arteries of the lower limbs.
- Adult person (age> 18).
- Affiliated with a social security scheme.
- Signature of informed consent.
Who cannot join
- Patients with a history of coronary artery disease awaiting revascularization.
- Hyperthyroidism, anemia (Hb <13 g / dL).
- Contraindication to the practice of coronary angiography, stress echocardiography or myocardial scintigraphy.
- Unstable hemodynamic state or cardiogenic shock.
- Adults protected under guardianship, curatorship or legal protection.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hopitaux de Marseille
Marseille
PIERRE DEHARO
About this study
The chronic coronary artery disease could be detected by a drop in the expression of A2A receptors to adenosine, while high values of the KD / EC50 ratio are a sign of coronary ischemia. Knowing the number of A2A receptors in circulating lymphocytes could allow detection of coronary artery disease and evaluating the functionality of A2A receptors in circulating lymphocytes could allow quantification of myocardial ischemia.
Thus, a simple and unique blood sample would quickly detect patients with life-threatening coronary ischemia. This would avoid prolonged hospitalizations and costly non-invasive tests (stress echocardiography, myocardial scintigraphy) in patients without coronary artery disease.
Read the detailed description
The main objective of this study is to evaluate the discriminating capacities of A2A adenosine receptors expression on the surface of circulating lymphocytes for the detection of coronary artery disease in patients hospitalized for surgery of the aorta and / or arteries of the lower limbs.
The secondary objectives are:
Assessment of the discriminating capacities of the functionality (KD / EC50) of A2A adenosine receptors on the surface of circulating lymphocytes, for the diagnosis of myocardial ischemia in patients hospitalized for surgery of the aorta and / or arteries of legs.
Determinate the best threshold for discriminating patients with coronary artery disease and estimate the discriminating performance associated with this threshold.
Determinate the best threshold for discriminating patients with myocardial ischemia and estimate the discriminating performance associated with this threshold.
- Conditions
- Chronic Coronary Artery Disease
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
measuring the expression and function of lymphocyte A2A receptors.
| Study group | Role | What they receive |
|---|---|---|
| patients hospitalized | Experimental | for surgery of the aorta and / or arteries of the lower limbs. Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of adenosine
measuring the expression and function of lymphocyte A2A receptors.
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 posted23 Nov 2020
- Study start25 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO PRADALIE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640844
- Sponsor's protocol ID
- 2020-13
- Other IDs
- 2020-A00686-33
- Acronym
- RIMACI
- Status last verified
- May 2021
- First submitted
- 12 Nov 2020
- Last updated
- 28 May 2021
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT04640844
- Acronym / sponsor ID
- RIMACI / 2020-13
- Conditions
- Chronic Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 23 Nov 2020 (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.
The chronic coronary artery disease could be detected by a drop in the expression of A2A receptors to adenosine, while high values of the KD / EC50 ratio are a sign of coronary ischemia. Knowing the number of A2A receptors in circulating lymphocytes could allow detection of coronary artery disease and evaluating the functionality of A2A receptors in circulating lymphocytes could allow quantification of myocardial ischemia.
Thus, a simple and unique blood sample would quickly detect patients with life-threatening coronary ischemia. This would avoid prolonged hospitalizations and costly non-invasive tests (stress echocardiography, myocardial scintigraphy) in patients without coronary artery disease.
Detailed description
The main objective of this study is to evaluate the discriminating capacities of A2A adenosine receptors expression on the surface of circulating lymphocytes for the detection of coronary artery disease in patients hospitalized for surgery of the aorta and / or arteries of the lower limbs.
The secondary objectives are:
Assessment of the discriminating capacities of the functionality (KD / EC50) of A2A adenosine receptors on the surface of circulating lymphocytes, for the diagnosis of myocardial ischemia in patients hospitalized for surgery of the aorta and / or arteries of legs.
Determinate the best threshold for discriminating patients with coronary artery disease and estimate the discriminating performance associated with this threshold.
Determinate the best threshold for discriminating patients with myocardial ischemia and estimate the discriminating performance associated with this threshold.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients hospitalized | Experimental | Biological: blood samplefor surgery of the aorta and / or arteries of the lower limbs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted for preoperative assessment of vascular surgery of the aorta and / or arteries of the lower limbs.
- Adult person (age> 18).
- Affiliated with a social security scheme.
- Signature of informed consent.
Key exclusion criteria (6 listed)
- Patients with a history of coronary artery disease awaiting revascularization.
- Hyperthyroidism, anemia (Hb <13 g / dL).
- Contraindication to the practice of coronary angiography, stress echocardiography or myocardial scintigraphy.
- Unstable hemodynamic state or cardiogenic shock.
- Adults protected under guardianship, curatorship or legal protection.
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 samplemeasuring the expression and function of lymphocyte A2A receptors. | Biological | patients hospitalized |
Primary outcome
Dosage of adenosine
Time frame: 24 MONTHS
measuring the expression and function of lymphocyte A2A receptors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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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.
Emilie GARRIDO PRADALIE 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 sample in people with Chronic Coronary Artery Disease, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ALAEXANDRA GIULIANI (0491382747, alexandra.giuliani@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of adenosine (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 28 May 2021.