Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island

Cardiovascular Disease Clinical Trial

— COLLIPAR  

Official title:

Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310917
• Other study ID #: 2020/CHU/01
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2020
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Lucie AUZANNEAU
• Phone: 0262359949
• Email: lucie.auzanneau[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cardiovascular disease (CVD) is the second leading cause of death in France and the leading cause of death on Reunion Island. Some modifiable risk factors for cardiovascular diseases are well identified and can be easily modulated, in particular by hygiene and dietetic measures (tobacco, sedentary lifestyle). Other risk factors such as high blood pressure, diabetes or dyslipidemia can also be pharmacologically modulated. On the other hand, there is a cardiovascular risk factor that we do not know how to modulate: a high level of lipoprotein (a) (Lp (a)), whose regulation remains largely unknown.

High plasma levels of Lipoprotein (a) remain a major risk for the development of cardiovascular disease and its clinical complications, which no drug can currently reduce. Understanding the biological and genetic determinants modulating Lp (a) levels remains a major challenge for treating subjects with hyper Lp (a). Several individuals and possibly Reunion families have been detected as having abnormally high rates of apo (a)

Thanks to the link between cardiovascular clinical picture, Lp (a) concentration and other biological markers, the study should allow a better understanding of the mechanisms underlying the cardiovascular risk in order to offer advice. prevention and care of at-risk subjects screened; or even avenues for adapted genetic counseling (DNA sequencing).

At the genetic level, several hypotheses could be explored making it possible to link the expression of the apo (a) protein to the genotype, in particular the presence of mutations in the gene, in the promoter region, polymorphisms, or epistatic regulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient with Lp (a)> 200 nmol / L OR member of family of a patient with Lp (a)> 200 nmol / L

• be affiliated or beneficiary of a social security scheme

• signed consent

Exclusion Criteria:

• Refusal to participate

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• blood lipoprotein (a) test
research specific blood sample

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de la Réunion	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carry out a family screening of the plasma Lp (a) level	Carry out a family screening of the plasma Lp (a) level around index cases followed or directed towards Reunion University Hospital (index case = Lp (a) rate> 200nmol / L)	at inclusion