NCT00065793

Brief Summary

To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle types as predictors of initial coronary events.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,478

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

July 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

4.9 years

First QC Date

July 31, 2003

Last Update Submit

January 30, 2015

Conditions

Cardiovascular DiseasesHeart DiseasesCoronary DiseaseMyocardial InfarctionDiabetes MellitusDiabetes Mellitus, Non-insulin Dependent

Outcome Measures

Primary Outcomes (1)

  • apoB concentration of LDL with apoC-III

    observational follow-up for coronary events

    10-14 years

Eligibility Criteria

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

Nurses Health Study Health Professionals Follow-up Study

Cases having first coronary event

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

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesCoronary DiseaseMyocardial InfarctionDiabetes MellitusDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Frank Sacks, MD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Frank Sacks, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 31, 2003

First Posted

August 4, 2003

Study Start

July 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 3, 2015

Record last verified: 2015-01