NCT00074464

Brief Summary

To investigate the predictive value of using measures of cholesterol homeostasis to identify individuals at high risk of developing cardiovascular disease relative to established risk factors.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,378

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2003

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

August 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 6, 2013

Status Verified

May 1, 2013

Enrollment Period

4.9 years

First QC Date

December 12, 2003

Last Update Submit

May 3, 2013

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisCoronary Disease

Outcome Measures

Primary Outcomes (1)

  • quantification of circulating indicators of cholesterol homeostasis

    phytosterols and cholestanol (surrogate measures of cholesterol absorption) cholesterol precursors (surrogate measures of cholesterol synthetic rates)

    1 time point

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Framingham Offspring Study Cycle 6 Participants

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 (1)

  • Matthan NR, Zhu L, Pencina M, D'Agostino RB, Schaefer EJ, Lichtenstein AH. Sex-specific differences in the predictive value of cholesterol homeostasis markers and 10-year cardiovascular disease event rate in Framingham Offspring Study participants. J Am Heart Assoc. 2013 Feb 19;2(1):e005066. doi: 10.1161/JAHA.112.005066.

    PMID: 23525441DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesAtherosclerosisCoronary Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial Ischemia

Study Officials

  • Alice Lichtenstein

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2003

First Posted

December 15, 2003

Study Start

August 1, 2003

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 6, 2013

Record last verified: 2013-05