NCT00106483

Brief Summary

To test the primary hypothesis that individuals with pre-clinical connective tissue disease related autoimmunity are more likely to demonstrate subsequent development of sub-clinical coronary artery disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,020

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

2.9 years

First QC Date

March 24, 2005

Last Update Submit

March 18, 2015

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart Diseases

Keywords

Cardiovascular DiseasesCoronary DiseaseHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Coronary artery calcification (CAC)

    serum samples already collected by they CARDIA study in 1992 were tested by our ancillary study for autoantibodies and we analyzed whether autoantibody positivity was associated with CAC over 13 years of follow up in the CARDIA study. CAC was measured by the CARDIA study in 2000 and 2005.

    8 years

Study Arms (1)

Coronary Artery Risk Development in Young Adults

There were no interventions.

Eligibility Criteria

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

All CARDIA participants with serum available in 1992 and coronary calcification measure in years 2000 and 2005.

No eligibility criteria

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 DiseasesCoronary DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular Diseases

Study Officials

  • Darcy Majka, MD MS

    Northwestern University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Medicine & Preventive Medicine

Study Record Dates

First Submitted

March 24, 2005

First Posted

March 25, 2005

Study Start

February 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

March 19, 2015

Record last verified: 2015-03