NCT00024596

Brief Summary

To determine familial and non-familial causes for susceptibility to atherosclerosis and the inflammatory response.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,389

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

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

September 1, 2001

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

September 21, 2001

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

4.9 years

First QC Date

September 21, 2001

Last Update Submit

December 21, 2015

Conditions

Study Arms (2)

Caucasian Families

Largest 3-generational Caucasian Families from Family Heart Study (Classic) with average family size of 10 N=2767 Subjects from 512 families. Approximately half are random sample families from FamHS-Classic, and half are high-familial CHD risk families from FamHS-Classic. 4 Field sites were Raleigh-Durham North Carolina; Minneapolis, MN; Framingham MA; and Salt Lake City, UT.

African-American Families

622 subjects from 2-3 generational 212 African-American families originally recruited from the HyperGEN study in Birmingham AL. These are hypertension enriched families.

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Djousse L, Arnett DK, Carr JJ, Eckfeldt JH, Hopkins PN, Province MA, Ellison RC; Investigators of the NHLBI FHS. Dietary linolenic acid is inversely associated with calcified atherosclerotic plaque in the coronary arteries: the National Heart, Lung, and Blood Institute Family Heart Study. Circulation. 2005 Jun 7;111(22):2921-6. doi: 10.1161/CIRCULATIONAHA.104.489534. Epub 2005 May 31.

    PMID: 15927976BACKGROUND
  • Ellison RC, Zhang Y, Wagenknecht LE, Eckfeldt JH, Hopkins PN, Pankow JS, Djousse L, Carr JJ. Relation of the metabolic syndrome to calcified atherosclerotic plaque in the coronary arteries and aorta. Am J Cardiol. 2005 May 15;95(10):1180-6. doi: 10.1016/j.amjcard.2005.01.046.

    PMID: 15877990BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Stored DNA, lymphoblasts

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisCoronary Artery Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary DiseaseMyocardial Ischemia

Study Officials

  • John Carr

    Wake Forest University

  • John Eckfeldt

    University of Minnesota

  • R. Ellison

    Boston University

  • Gerardo Heiss

    University of North Carolina

  • James Hixson

    University of Texas

  • Steven Hunt

    University of Utah

  • Cora Lewis

    University of Alabama at Birmingham

  • James Pankow

    University of Minnesota

  • Michael Province

    Washington University School of Medicine

  • Lynne Wagenknecht

    Wake Forest University

Study Design

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

Study Record Dates

First Submitted

September 21, 2001

First Posted

September 21, 2001

Study Start

September 1, 2001

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

December 22, 2015

Record last verified: 2015-12