Cardiovascular DiseasesCDPA-BiobankNCT04809506
Identification of New Biomarkers for the Prediction of Cardiovascular Events
An observational study of Cardiovascular Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- additional blood samples
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2021to 3 Feb 2034
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) for management of their cardiovascular risk factors; patients on primary prevention, free of personal history of coronary artery disease, stroke or lower limb arteriopathy, or patients on secondary prevention having presented one of the above mentioned diseases
Who may be able to join
- Adults over 18 yrs;
- consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) for management of their cardiovascular risk factors;
- patients on primary prevention, free of personal history of coronary artery disease, stroke or lower limb arteriopathy, or patients on secondary prevention having presented one of the above mentioned diseases;
- patients affiliated to a health insurance system;
- patients having given their written informed consent for a participation to the study and for possible genetic analysis of their personal traits.
Who cannot join
- Patients under the age of 18;
- patients being under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Jean Ferrières, PU-PH, 562323728 ext. 0033, ferrieres.j@chu-toulouse.fr
About this study
Official title: Bio-collection for the Discovery of New Biomarkers for the Prediction of Cardiovascular Events
The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. The main objective is to validate new biomarkers with prognostic value regarding the onset of future CV events. Besides, the biological collection will enable patho-physiological studies on atherosclerosis related diseases.
Read the detailed description
Cardiovascular (CV) diseases, particularly those secondary to atherosclerosis, are a leading cause of morbidity and mortality in modern societies. Classical CV risk factors, including age and gender, family history, tobacco smoking, hypertension, diabetes, dyslipidemia and obesity cannot predict more than 50% of future CV events. Use of specific scores (like the SCORE chart) does not much contribute to the precise evaluation of patients classified at moderate risk. Thus, more research is needed: 1) to study patho-physiological mechanisms of the atherothrombotic process in order to identify new pharmacological targets and, 2) to validate new biomarkers with a strong predictive value regarding the onset of hard CV clinical events. Moreover, genetic polymorphisms underlie an individual's susceptibility to develop atherosclerotic diseases. Identification of those gene variants might help to define a personalized approach for the treatment of CV diseases. Patients consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) are submitted to a personal face-to-face interview addressing their life style, nutritional and smoking habits, and their physical activity practice. Clinical examination includes ECG, stress test, ankle-arm systolic index, ultrasonography of arteries (carotid, aorta, lower limb) and determination of a coronary calcification score. Blood samples are taken up for chemistry measurements including lipoproteins (triglycerides, LDL-C, HDL-C, Lp(a)). For the specific purpose of the biological collection, two supplementary blood tubes will be collected (2 x 7 ml); serum, plasma and genomic DNA will be prepared. Patients will be followed up yearly for those on secondary prevention and every 2nd year on primary prevention. Identical investigation will be carried out at every visit. Recruitment period will spread over 5 years and follow-up will be pursued up to 8 years.
- Conditions
- Cardiovascular Diseases
- Being tested
- additional blood samples
- Keywords
- Arterial disease, atherosclerosis, Thrombosis, Biomarkers, Genetic polymorphisms
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood samplesBiological
2 additional blood samples (2 x 7ml) at every visit
| Study group | Role | What they receive |
|---|---|---|
| Patient consulting the Centre for Screening and Prevention of Atherosclerosis | 2 additional blood samples (2 x 7ml) at every visit Receives: Biological: additional blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the candidate biomarker
measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.
Measured: Day 0
measurement of the candidate biomarker
measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.
Measured: during the intervention/procedure/surgery
Secondary outcomes (2)
evolution of clinical and biological parameters involved in atherothrombosis
Pathophysiological mechanisms involved in atherothrombosis will be investigated using biomarkers addressing specific pathways: lipid metabolism, inflammation, endothelial reactivity, myocardial function. For a given new biomarker, its transferability to a clinical lab will be evaluated by its analytical performances and its possible adaptation to a semi-automated platform.
Measured: Day 0
evolution of clinical and biological parameters involved in atherothrombosis
Pathophysiological mechanisms involved in atherothrombosis will be investigated using biomarkers addressing specific pathways: lipid metabolism, inflammation, endothelial reactivity, myocardial function. For a given new biomarker, its transferability to a clinical lab will be evaluated by its analytical performances and its possible adaptation to a semi-automated platform.
Measured: during the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start4 Feb 2021
- Primary completion3 Feb 2030 (estimated)
- Study completion3 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Ferrieres, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809506
- Sponsor's protocol ID
- RC31/21/0116
- Acronym
- CDPA-Biobank
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2021
- Last updated
- 19 Mar 2026
- 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 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-collection for the Discovery of New Biomarkers for the Prediction of Cardiovascular Events
- ClinicalTrials.gov ID
- NCT04809506
- Acronym / sponsor ID
- CDPA-Biobank / RC31/21/0116
- Conditions
- Cardiovascular Diseases
- Keywords
- Arterial disease, atherosclerosis, Thrombosis, Biomarkers, Genetic polymorphisms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 3 Feb 2030 (estimated)
- Study completion
- 3 Feb 2034 (estimated)
- First posted
- 22 Mar 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.
The main goal of this project is to constitute a collection of biological samples, obtained through the clinical activity of the Centre for Screening and Prevention of Atherosclerosis at Toulouse University Hospital, managing patients in primary or secondary prevention for cardiovascular (CV) diseases. The main objective is to validate new biomarkers with prognostic value regarding the onset of future CV events. Besides, the biological collection will enable patho-physiological studies on atherosclerosis related diseases.
Detailed description
Cardiovascular (CV) diseases, particularly those secondary to atherosclerosis, are a leading cause of morbidity and mortality in modern societies. Classical CV risk factors, including age and gender, family history, tobacco smoking, hypertension, diabetes, dyslipidemia and obesity cannot predict more than 50% of future CV events. Use of specific scores (like the SCORE chart) does not much contribute to the precise evaluation of patients classified at moderate risk. Thus, more research is needed: 1) to study patho-physiological mechanisms of the atherothrombotic process in order to identify new pharmacological targets and, 2) to validate new biomarkers with a strong predictive value regarding the onset of hard CV clinical events. Moreover, genetic polymorphisms underlie an individual's susceptibility to develop atherosclerotic diseases. Identification of those gene variants might help to define a personalized approach for the treatment of CV diseases. Patients consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) are submitted to a personal face-to-face interview addressing their life style, nutritional and smoking habits, and their physical activity practice. Clinical examination includes ECG, stress test, ankle-arm systolic index, ultrasonography of arteries (carotid, aorta, lower limb) and determination of a coronary calcification score. Blood samples are taken up for chemistry measurements including lipoproteins (triglycerides, LDL-C, HDL-C, Lp(a)). For the specific purpose of the biological collection, two supplementary blood tubes will be collected (2 x 7 ml); serum, plasma and genomic DNA will be prepared. Patients will be followed up yearly for those on secondary prevention and every 2nd year on primary prevention. Identical investigation will be carried out at every visit. Recruitment period will spread over 5 years and follow-up will be pursued up to 8 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient consulting the Centre for Screening and Prevention of Atherosclerosis | – | Biological: additional blood samples2 additional blood samples (2 x 7ml) at every visit |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) for management of their cardiovascular risk factors; patients on primary prevention, free of personal history of coronary artery disease, stroke or lower limb arteriopathy, or patients on secondary prevention having presented one of the above mentioned diseases
Key inclusion criteria (5 listed)
- Adults over 18 yrs;
- consulting the Centre for Screening and Prevention of Atherosclerosis (CDPA) for management of their cardiovascular risk factors;
- patients on primary prevention, free of personal history of coronary artery disease, stroke or lower limb arteriopathy, or patients on secondary prevention having presented one of the above mentioned diseases;
- patients affiliated to a health insurance system;
- patients having given their written informed consent for a participation to the study and for possible genetic analysis of their personal traits.
Key exclusion criteria (2 listed)
- Patients under the age of 18;
- patients being under 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 |
|---|---|---|
| additional blood samples2 additional blood samples (2 x 7ml) at every visit | Biological | Patient consulting the Centre for Screening and Prevention of Atherosclerosis |
Primary outcome
measurement of the candidate biomarker
Time frame: Day 0
measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.
measurement of the candidate biomarker
Time frame: during the intervention/procedure/surgery
measurement, at baseline of the candidate biomarker, with respect to the onset, during follow-up, of a cardiovascular event: either coronary events or cerebrovascular stroke or lower limb arteriopathy.
2 secondary outcomes
evolution of clinical and biological parameters involved in atherothrombosis
Time frame: Day 0
evolution of clinical and biological parameters involved in atherothrombosis
Time frame: during the intervention/procedure/surgery
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Jean Ferrieres, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University Hospital, Toulouse 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 5 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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?
Contact Jean Ferrières, MD PhD (562323728 ext. 0033, ferrieres.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of the candidate biomarker (time frame: Day 0). The study lists 2 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 19 Mar 2026.