NCT00064532

Brief Summary

To assess the associations of serum sex hormones with the presence and progression of subclinical atherosclerosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6,173

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
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2003

Completed
4.9 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

December 3, 2014

Status Verified

November 1, 2013

Enrollment Period

4.9 years

First QC Date

July 8, 2003

Last Update Submit

December 2, 2014

Conditions

Cardiovascular DiseasesAtherosclerosisCoronary ArteriosclerosisCoronary DiseaseHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Coronary artery calcium

    Baseline

Eligibility Criteria

Age45 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample of African-American, Chinese-American, Caucasian, and Hispanic residents drawn from six regions in the United States: Baltimore City and Baltimore County, Maryland; Chicago, Illinois; Forsyth County, North Carolina; Los Angeles County, California; New York, New York; and St. Paul, Minnesota.

You may not qualify if:

  • Age younger than 45 or older than 84 years
  • Physician-diagnosed heart attack
  • Physician-diagnosed angina or taking nitroglycerin
  • Physician-diagnosed stroke or TIA
  • Physician-diagnosed heart failure
  • Current atrial fibrillation
  • Having undergone procedures related to cardiovascular disease (CABG, angioplasty, valve replacement, pacemaker or defibrillator implantation, any surgery on the heart or arteries)
  • Active treatment for cancer
  • Pregnancy
  • Any serious medical condition which would prevent long-term participation
  • Weight \>300 pounds
  • Cognitive inability as judged by the interviewer
  • Living in a nursing home or on the waiting list for a nursing home
  • Plans to leave the community within five years
  • Language barrier (speaks other than English, Spanish, Cantonese or Mandarin)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosisCoronary Artery DiseaseCoronary DiseaseHeart Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial Ischemia

Study Officials

  • Susan Gapstur

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Preventive Medicine and Geriatrics and Internal Medicine

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 10, 2003

Study Start

July 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

December 3, 2014

Record last verified: 2013-11