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Identification of New Biomarkers for the Prediction of Cardiovascular Events

NCT ID: NCT04809506

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-04

Study Completion Date

2034-02-03

Brief Summary

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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

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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

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Cardiovascular Diseases

Keywords

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Arterial disease atherosclerosis Thrombosis Biomarkers Genetic polymorphisms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient consulting the Centre for Screening and Prevention of Atherosclerosis

2 additional blood samples (2 x 7ml) at every visit

additional blood samples

Intervention Type BIOLOGICAL

2 additional blood samples (2 x 7ml) at every visit

Interventions

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additional blood samples

2 additional blood samples (2 x 7ml) at every visit

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Ferrieres, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Ferrières, MD PhD

Role: CONTACT

Phone: 562323728

Email: [email protected]

Facility Contacts

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Jean Ferrières, PU-PH

Role: primary

Other Identifiers

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RC31/21/0116

Identifier Type: -

Identifier Source: org_study_id