Identification of New Biomarkers for the Prediction of Cardiovascular Events (CDPA-Biobank)

March 16, 2026 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31059
        • Recruiting
        • University Hospital Toulouse
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients under the age of 18;
  • patients being under legal protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient consulting the Centre for Screening and Prevention of Atherosclerosis
2 additional blood samples (2 x 7ml) at every visit
Biological: additional blood samples
2 additional blood samples (2 x 7ml) at every visit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
during the intervention/procedure/surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
evolution of clinical and biological parameters involved in atherothrombosis
Time Frame: Day 0
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.
Day 0
evolution of clinical and biological parameters involved in atherothrombosis
Time Frame: during the intervention/procedure/surgery
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.
during the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Ferrieres, MD PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/21/0116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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