NCT00627068

Brief Summary

Our main hypothesis is that EPC function is impaired in some populations with high cardiovascular risk as a result of reduced eNOS-dependent NO production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

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, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

3.4 years

First QC Date

February 21, 2008

Last Update Submit

September 16, 2011

Conditions

Cardiovascular Disease

Keywords

cardiovascularvasodilationendotheliumSubjects with high cardiovascular risk

Study Arms (4)

1

High cardiovascular risk age over 61 years.

2

Low Cardiovascular risk age over 61.

3

High cardiovascular risk age over 25 but under 61.

4

Low cardiovascular risk age over 25 under 61.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population in both low and high risk groups should represent the general population.

You may qualify if:

  • Willing and able to give written informed consent and comply with study requirements
  • Adult of 18 years or older
  • Subjects willing to provide blood and tissue samples

You may not qualify if:

  • Failure to give informed consent.
  • Those unable to consent for themselves.
  • Those who cannot read English.
  • Patients on Viagra, Levitra, or Cialis
  • Patients with malignant disease
  • Patients with hematological abnormalities
  • Patients with fevers of unknown origin
  • Severe comorbidity or alcohol/drug dependence
  • Women who are post-menopausal and on hormone replacement therapy, or premenopausal and on birth control pills (premenopausal women will be screened verbally and then by assay of LH and FSH levels in blood samples to identify women in the follicular phase of their menstrual cycle, to reduce variability)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF, Department of Cardiology

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Cardiovascular DiseasesAneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

  • Yerem Yeghiazarians, M.D

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

July 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

US(1)