HypercholesterolemiaRASCASNCT05017649
Role of A2A Receptor in Hypercholesterolemic Patients
A study testing Blood sample in people with Hypercholesterolemia, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (CVD). Treatment with lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors or LDL-apheresis) reduces the risk of major cardiovascular events in proportion to the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2021to 19 Jun 2026
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18-80 years
- For the group of hypercholesterolemic patients :
- LDL-cholesterol level >1.9 g/L with or without treatment to make the diagnosis of hypercholesterolemia (laboratory test less than 12 months old at inclusion)
- For the healthy group :
- ● No cholesterol-modifying therapy.
- Subject not having hypercholesterolemia (biological assessment less than 12 months old at inclusion with LDL-cholesterol level < 1.9 g/L) and not taking cholesterol-lowering treatment.
- Subjects who are affiliated or beneficiaries of a social security plan
- Subject agreeing to participate in the study and having signed an informed consent
Who cannot join
- Protected person, as defined by articles L1121-5, L1121-6 and L1121-8 of the Public Health Code: pregnant or breastfeeding woman, person deprived of liberty by judicial decision, adult person unable to give consent.
- Person who does not understand the French language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Endocrinologie
Marseille, 13005
René VALERO, MD, rene.valero@ap-hm.fr
About this study
Official title: Characterization of Adenosine A2A Receptor Expression and Fubnction in Hypercholesterolemic Patients
Hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (CVD). Treatment with lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors or LDL-apheresis) reduces the risk of major cardiovascular events in proportion to the absolute reduction of LDL-cholesterol (LDL-C). Nevertheless, a better understanding of the effects of hypercholesterolemia on the cardiovascular and immune systems could help identify all the mechanisms responsible for the excess risk of CVD in hypercholesterolemic patients and develop better prevention and treatment strategies.
Adenosine via A2A receptors (A2AR) plays a crucial role in the regulation of the cardiovascular and immune systems.
Read more
In this project, the investigators wish :
- To study whether the expression and function of A2AR in PBMCs are altered in human hypercholesterolemia, using as a study model a larger cohort of patients with hypercholesterolemia of increasing level and severity: polygenic form, heterozygous genetic form and homozygous genetic form in comparison with healthy subjects with normal cholesterol levels.
- To study whether A2AR expression and function in PBMCs are associated with blood levels of LDL-C and homocysteine and with the inflammatory status of patients.
- To assess whether the cholesterol-lowering therapies currently used to reduce LDL-C levels and thus the risk of CVD in hypercholesterolemic patients have an impact on possible alterations of A2AR expression and function in PBMCs.
- Conditions
- Hypercholesterolemia
- Being tested
- Blood sample
- Keywords
- hypercholesterolemia, adenosine receptor, PBMC
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | volunteers showing no hypercholesterolemia Receives: Biological: Blood sample |
| Patients with untreated hypercholesterolemia at the time of inclusion | Experimental | patients presenting hypercholesterolemia with no treatment at the time of inclusion Receives: Biological: Blood sample |
| Patients with treated hypercholesterolemia at the time of inclusion | Experimental | patients presenting hypercholesterolemia and treated at the time of inclusion Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of A2AR expression in PBMCs
Comparison between hypercholesterolemic patients and healthy volunteers
Measured: Baseline
Quantification of A2AR expression in PBMCs
Comparison between hypercholesterolemic patients and healthy volunteers
Measured: 3 months after initiation of treatment
Quantification of A2AR function in PBMC
Comparison between hypercholesterolemic patients and healthy volunteers
Measured: 3 months after initiation of treatment
Quantification of A2AR function in PBMC
Comparison between hypercholesterolemic patients and healthy volunteers
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start20 Sep 2021
- Primary completion19 Mar 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017649
- Sponsor's protocol ID
- 2021-07
- Other IDs
- ID-RCB
- Acronym
- RASCAS
- Status last verified
- Jul 2023
- First submitted
- 17 Aug 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Adenosine A2A Receptor Expression and Fubnction in Hypercholesterolemic Patients
- ClinicalTrials.gov ID
- NCT05017649
- Acronym / sponsor ID
- RASCAS / 2021-07
- Conditions
- Hypercholesterolemia
- Keywords
- hypercholesterolemia, adenosine receptor, PBMC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 19 Mar 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 24 Aug 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.
Hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (CVD). Treatment with lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors or LDL-apheresis) reduces the risk of major cardiovascular events in proportion to the absolute reduction of LDL-cholesterol (LDL-C). Nevertheless, a better understanding of the effects of hypercholesterolemia on the cardiovascular and immune systems could help identify all the mechanisms responsible for the excess risk of CVD in hypercholesterolemic patients and develop better prevention and treatment strategies.
Adenosine via A2A receptors (A2AR) plays a crucial role in the regulation of the cardiovascular and immune systems.
In this project, the investigators wish :
- To study whether the expression and function of A2AR in PBMCs are altered in human hypercholesterolemia, using as a study model a larger cohort of patients with hypercholesterolemia of increasing level and severity: polygenic form, heterozygous genetic form and homozygous genetic form in comparison with healthy subjects with normal cholesterol levels.
- To study whether A2AR expression and function in PBMCs are associated with blood levels of LDL-C and homocysteine and with the inflammatory status of patients.
- To assess whether the cholesterol-lowering therapies currently used to reduce LDL-C levels and thus the risk of CVD in hypercholesterolemic patients have an impact on possible alterations of A2AR expression and function in PBMCs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Biological: Blood samplevolunteers showing no hypercholesterolemia |
| Patients with untreated hypercholesterolemia at the time of inclusion | Experimental | Biological: Blood samplepatients presenting hypercholesterolemia with no treatment at the time of inclusion |
| Patients with treated hypercholesterolemia at the time of inclusion | Experimental | Biological: Blood samplepatients presenting hypercholesterolemia and treated at the time of inclusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged 18-80 years
- For the group of hypercholesterolemic patients :
- For the healthy group :
- ● No cholesterol-modifying therapy.
- Subject not having hypercholesterolemia (biological assessment less than 12 months old at inclusion with LDL-cholesterol level < 1.9 g/L) and not taking cholesterol-lowering treatment.
Key exclusion criteria (2 listed)
- Protected person, as defined by articles L1121-5, L1121-6 and L1121-8 of the Public Health Code: pregnant or breastfeeding woman, person deprived of liberty by judicial decision, adult person unable to give consent.
- Person who does not understand the French language
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 sampleBlood sampling. | Biological | Healthy volunteers, Patients with treated hypercholesterolemia at the time of inclusion, Patients with untreated hypercholesterolemia at the time of inclusion |
Primary outcome
Quantification of A2AR expression in PBMCs
Time frame: Baseline
Comparison between hypercholesterolemic patients and healthy volunteers
Quantification of A2AR expression in PBMCs
Time frame: 3 months after initiation of treatment
Comparison between hypercholesterolemic patients and healthy volunteers
Quantification of A2AR function in PBMC
Time frame: 3 months after initiation of treatment
Comparison between hypercholesterolemic patients and healthy volunteers
Quantification of A2AR function in PBMC
Time frame: Baseline
Comparison between hypercholesterolemic patients and healthy volunteers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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.
François CREMIEUX study director
AP-HM
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 Hypercholesterolemia, 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 8 inclusion and 2 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 27 Jul 2023. 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 René Valero (0491387577 ext. 33, rene.valero@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of A2AR expression in PBMCs (time frame: Baseline). The study lists 4 primary outcomes in all. 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 27 Jul 2023.