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

Sponsor

Centre Hospitalier Universitaire de la Réunion (Other)

Overall Status

Recruiting

CT.gov ID

NCT04310917

Collaborator

(none)

100

Enrollment

Location

Arm

20.4

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Other: blood lipoprotein (a) test	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 19, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Lipoprotein a level blood lipoprotein (a) test	Other: blood lipoprotein (a) test research specific blood sample

Arm

Intervention/Treatment

Other: Lipoprotein a level

blood lipoprotein (a) test

Other: blood lipoprotein (a) test

research specific blood sample

Outcome Measures

Primary Outcome Measures

Carry out a family screening of the plasma Lp (a) level [at inclusion]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de la Réunion	Saint-Denis		France	97400

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Investigators

Principal Investigator: Ilya KHANTALIN, PH, CHU de la Réunion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT04310917

Other Study ID Numbers:

2020/CHU/01

First Posted:

Mar 17, 2020

Last Update Posted:

Mar 29, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Mar 29, 2021