NCT00365235

Brief Summary

Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary heart disease (CHD). The purpose of this study is to identify the specific genes that predispose Mexican individuals to FCHL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
998

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 12, 2012

Status Verified

January 1, 2012

Enrollment Period

4.9 years

First QC Date

August 16, 2006

Last Update Submit

January 11, 2012

Conditions

Hyperlipidemia, Familial CombinedCoronary Disease

Outcome Measures

Primary Outcomes (1)

  • Identifying the specific genes that predispose Mexican individuals to FCHL

    Measured through the use of genetic samples

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study subjects are Mexicans visiting the Dyslipidemia Clinic at the Instituto Nacional de Ciencias Medicas y Nutricion, Salvador Zubiran, Mexico City, and their family members

You may qualify if:

  • Elevated levels of serum total cholesterol, triglycerides, or both
  • Elevated levels of serum apolipoprotein B (using the Mexican population percentiles)

You may not qualify if:

  • Tendon xanthomas
  • Kidney disease
  • Thyroid disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional De Ciencias Medicas y Nutricion

Mexico City, 14000, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample is taken from all participants and adipose tissue sample from a subgroup.

MeSH Terms

Conditions

Hyperlipidemia, Familial CombinedCoronary Disease

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Paivi E. Pajukanta, MD, PhD

    David Geffen School of Medicine at UCLA, Department of Human Genetics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2006

First Posted

August 17, 2006

Study Start

July 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 12, 2012

Record last verified: 2012-01

Locations

ME(1)