NCT00380185

Brief Summary

Atherosclerosis, a condition in which fatty deposits build up along the inner walls of arteries, can occur throughout the body. The purpose of this study is to examine the possible genetic differences that may influence where atherosclerosis occurs.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,789

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

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

April 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

4.3 years

First QC Date

September 22, 2006

Last Update Submit

May 27, 2015

Conditions

Keywords

Peripheral Arterial DiseaseAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Identifying genetic variations that may cause inherited differences in plaque distribution

    Measured at participants' study visit

Study Arms (3)

1

Subjects with no hemodynamically significant disease (NHSD) of the coronary or peripheral arteries

2

Subjects with coronary artery disease only

3

Subjects with both coronary artery disease and peripheral arterial disease

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects are recruited from individuals undergoing elective coronary angiography for suspected CAD at Stanford University or Mount Sinai Medical Centers.

You may qualify if:

  • Hemodynamically significant PAD, as documented by an ankle-brachial index less than 0.9; control group participants will not have PAD
  • Received a referral for an elective coronary angiogram
  • Suspected CAD

You may not qualify if:

  • History of radiation treatment
  • History of organ transplant
  • History of viral diseases (i.e. HIV, hepatitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Related Publications (2)

  • Flores AM, Schuler A, Eberhard AV, Olin JW, Cooke JP, Leeper NJ, Shah NH, Ross EG. Unsupervised Learning for Automated Detection of Coronary Artery Disease Subgroups. J Am Heart Assoc. 2021 Dec 7;10(23):e021976. doi: 10.1161/JAHA.121.021976. Epub 2021 Nov 30.

  • Sadrzadeh Rafie AH, Stefanick ML, Sims ST, Phan T, Higgins M, Gabriel A, Assimes T, Narasimhan B, Nead KT, Myers J, Olin J, Cooke JP. Sex differences in the prevalence of peripheral artery disease in patients undergoing coronary catheterization. Vasc Med. 2010 Dec;15(6):443-50. doi: 10.1177/1358863X10388345.

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, White Cells

MeSH Terms

Conditions

Peripheral Vascular DiseasesPeripheral Arterial DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • John P. Cooke, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 22, 2006

First Posted

September 25, 2006

Study Start

April 1, 2004

Primary Completion

July 1, 2008

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations