NCT00853775

Brief Summary

The purpose of this study is to determine whether lipoprotein(a), also called Lp(a), is a risk factor for cardiovascular (heart) disease. Lipoproteins are tiny particles that circulate in the blood. They contain cholesterol, fat, and protein in varying amounts depending on the body's need. Higher levels of lipoproteins in the blood can cause an increased risk of heart disease. The investigators believe that by studying the Lp(a) lipoprotein in Caucasians and African Americans, the investigators can assess for genetic variation factors related to cardiovascular (heart) disease. The investigators will be looking at 100 African-American families and 100 Caucasian families to confirm whether a higher Lp(a) level is an indicator of a higher risk for heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

February 25, 2009

Last Update Submit

May 25, 2017

Conditions

Keywords

heart diseasecardiovascular diseaselipoproteinslipoprotein(a)Lp(a)apolipoprotein(a)apo(a)fatsproteinsmetabolism

Outcome Measures

Primary Outcomes (1)

  • Genetic variation of Lp(a) levels in each group

    five years

Study Arms (2)

African American Families

Families with 2 parents and 2 children - no intervention, observational study

Other: No intervention, observational study

Caucasian Families

Families with 2 parents and 2 children - no intervention, observational study

Other: No intervention, observational study

Interventions

African American FamiliesCaucasian Families

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We are recruiting 100 African American and 100 Caucasian families. The families that will be recruited will have two natural parents and two natural offspring.

You may qualify if:

  • Of Caucasian or African descent
  • Families must have 2 natural/biological parents and 2 natural/biological offspring
  • years old or older

You may not qualify if:

  • Races other than African American or Caucasian
  • Families without 2 natural/biological parents and 2 natural/biological offspring
  • younger that 6 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis CTSC Clinical Research Center (CCRC) at Veterans Affair Medical Center

Mather, California, 95655, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, DNA, white blood cell

MeSH Terms

Conditions

Heart DiseasesCardiovascular Diseases

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Lars Berglund, M.D., Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2009

First Posted

March 2, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations